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Amnio‐infusion en cas de rupture prématurée des membranes avant terme au troisième trimestre

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Referencias

References to studies included in this review

Gonzalez 2001 {published data only}

Gonzalez R, Malde J, Carrillo MP, Sancho‐Minano J, Garrote A, Munoz A, et al. The use of amnioinfusion in preterm deliveries. Preliminary results [abstract]. Journal of Perinatal Medicine 2001;29 Suppl 1(Pt 2):629.

Nageotte 1985 {published data only}

Nageotte MP, Freeman RK, Garite TJ, Dorchester W. Prophylactic intrapartum amnioinfusion in patients with preterm premature rupture of membranes. American Journal of Obstetrics and Gynecology 1985;153:557‐62.

Puertas 2007 {published data only}

Puertas A, Tirado P, Perez I, Lopez MS, Montoya F, Canizares JM, et al. Transcervical intrapartum amnioinfusion for preterm premature rupture of the membranes. European Journal of Obstetrics & Gynecology and Reproductive Biology 2007;131(1):40‐4.

Singla 2010 {published data only}

Singla A, Yadav P, Vaid NB, Suneja A, Faridi MMA. Transabdominal amnioinfusion in preterm premature rupture of membranes. International Journal of Gynecology & Obstetrics 2010;108:199‐202.

Tranquilli 2005 {published data only}

Tranquilli AL, Giannubilo SR, Bezzeccheri V, Scagnoli C. Transabdominal amnioinfusion in preterm premature rupture of membranes: a randomised controlled trial. BJOG: an international journal of obstetrics and gynaecology 2005;112(6):759‐63.

References to studies excluded from this review

De Santis 2003 {published data only}

De Santis M, Scavo M, Noia G, Masini L, Piersigilli F, Romagnoli C, et al. Transabdominal amnioinfusion treatment of severe oligohydramnios in preterm premature rupture of membranes at less than 26 gestational weeks. Fetal Diagnosis and Therapy 2003;18(6):412‐7.

Gowri 2004 {published data only}

Gowri R, Soundaraghavan S. Evaluation of transabdominal amnioinfusion in the antepartum management of oligohydramnios complicating preterm pregnancies. Journal of Obstetrics and Gynaecology of India 2004;54(5):460‐3.

Locatelli 2000 {published data only}

Locatelli A, Vergani P, Di Pirro G, Doria V, Biffi A, Ghidini A. Role of amnioinfusion in the management of premature rupture of membranes at < 26 weeks gestation. American Journal of Obstetrics and Gynecology 2000;183:878‐82.

Mino 1999 {published data only}

Mino M, Puertas A, Carrillo M, Santiago J, Herruzo A, Miranda J. Influence of amnioinfusion on variable or prolonged decelarations: a randomised study. Acta Obstetricia et Gynecologica Scandinavica 1997;76:95.
Mino M, Puertas A, Herruzo AJ, Miranda JA. Amnioinfusion in labor induction of term pregnancies with premature rupture of the membranes and low amniotic fluid. International Journal of Gynecology & Obstetrics 1998;61:135‐40.
Mino M, Puertas A, Miranda JA, Herruzo AJ. Amnioinfusion in term labor with low amniotic fluid due to rupture of membranes: a new indication. European Journal of Obstetrics & Gynecology and Reproductive Biology 1999;82:29‐34.
Mino M, Puertas A, Mozas J, Carrillo Badillo MP, Rodríguez Oliver A, Miranda JA. A modification of the amniotic fluid index after amnioinfusion for infants with early rupture of membranes [Modificacion del indice de liquido amniotico tras amnioinfusion en gestantes con rotura prematura de membranas a termino]. Acta Ginecologica 1997;51(1):11‐4.
Puertas A, Mino M, Carrillo M, Mozas J, Herruzo A, Miranda J. Influence of amnioinfusion on neonatal acid‐base state: a randomized study. Acta Obstetricia et Gynecologica Scandinavica Supplement 1997;76:94.

Roberts: AMIPROM {unpublished data only}

Roberts D, Alfirevic Z, Bricker L, Beardsmore C, Paturi P, Taylor S, et al. Amnioinfusion in preterm premature rupture of membranes (AMIPROM study). Current Controlled Trials (www.controlled‐trials.com/) (accessed 17 December 2013).
Roberts D, Beardsmore C, Shaw B, Martin W, Vause S, Bricker L, et al. AMIPROM: a pilot RCT on serial transabdominal amnioinfusion versus expectant management in very early PROM. Ultrasound in Obstetrics & Gynecology 2012;40(Suppl 1):80.
Roberts D, Vause S, Martin W, Green P, Walkinshaw S, Bricker L, et al. Amnioinfusion in very early preterm premature rupture of membranes ‐ pregnancy, neonatal and maternal outcomes in the AMIPROM randomised controlled pilot study. Ultrasound in Obstetrics & Gynecology 2013 Nov 21 [Epub ahead of print].
Roberts D, Vause S, Martin W, Green P, Walkinshaw S, Bricker L, et al. Pregnancy outcomes in AMIPROM: a pilot RCT on serial transabdominal amnioinfusion versus expectant management in very early preterm prelabour rupture of membranes. BJOG: an international journal of obstetrics and gynaecology 2013;120(Suppl s1):10.

Vergani 2007 {published data only}

Vergani P, Deprest J, Strobelt N, Locatelli A. Proposal for open randomized trial comparing perinatal outcome following expectant management versus amnioinfusion in PPROM < 25 weeks with persistent oligohydramnios (amnioinfusion initiative). Ultrasound in Obstetrics and Gynecology 2007;30:541.

Gabbe 1976

Gabbe SG, Ettinger BB, Freeman RK, Martin CB. Umbilical cord compression associated with amniotomy: laboratory observations. American Journal of Obstetrics and Gynecology 1976;126(3):353‐5.

Goodlin 1981

Goodlin RC. Intra‐amniotic antibiotic infusions. American Journal of Obstetrics and Gynecology 1981;139(8):975.

Higgins 2011

Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated September 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.

Hofmeyr 2012

Hofmeyr GJ, Lawrie TA. Amnioinfusion for potential or suspected umbilical cord compression in labour. Cochrane Database of Systematic Reviews 2012, Issue 1. [DOI: 10.1002/14651858.CD000013.pub2]

Hofmeyr 2014

Hofmeyr GJ, Xu H, Eke AC. Amnioinfusion for meconium‐stained liquor in labour. Cochrane Database of Systematic Reviews 2014, Issue 1. [DOI: 10.1002/14651858.CD000014.pub4]

Hsu 2009

Hsu TY, Hsu JJ, Fu HC, Ou CY, Tsai CC, Cheng BH, et al. The changes in Doppler indices of fetal ductus venosus and umbilical artery after amnioinfusion for women with preterm premature rupture of membranes before 26 weeks' gestation. Taiwan Journal of Obstetrics and Gynecology 2009;48(3):268‐72.

Keirse 1989

Keirse MJNC, Ohlsson A, Treffers PE, Kanhai HHH. Prelabour rupture of the membranes preterm. In: Chalmers I, Enkin MW, Keirse MJNC editor(s). Effective Care in Pregnancy and Childbirth. Oxford: Oxford University Press, 1989:666‐93.

Locatelli 2006

Locatelli A, Ghidini A, Verderio M, Andreani M, Strobelt N, Pezzullo J, et al. Predictors of perinatal survival in a cohort of pregnancies with severe oligohydramnios due to premature rupture of membranes at < 26 weeks managed with serial infusions. European Journal of Obstetrics & Gynecology and Reproductive Biology 2006;128(1‐2):97‐102.

Miyazaki 1983

Miyazaki FS, Taylor NA. Saline amnioinfusion for relief of prolonged variable decelerations. American Journal of Obstetrics and Gynecology 1983;146:670‐8.

Monahan 1995

Monahan E, Katz VL, Cox RL. Amnioinfusion for preventing puerperal infection. A prospective study. Journal of Reproductive Medicine 1995;40(10):721‐3.

Novikova 2012

Novikova N, Hofmeyr GJ, Essilfie‐Appiah G. Prophylactic versus therapeutic amnioinfusion for oligohydramnios in labour. Cochrane Database of Systematic Reviews 2012, Issue 9. [DOI: 10.1002/14651858.CD000176.pub2]

Ogita 1988

Ogita S, Imanaka M, Matsumoto M, Oka T, Sugawa T. Transcervical amnioinfusion of antibiotics: a basic study for managing premature rupture of membranes. American Journal of Obstetrics and Gynecology 1988;158(1):23‐7.

Ogunyemi 2002

Ogunyemi D, Thompson W. A case controlled study of serial transabdominal amnioinfusions in the management of second trimester oligohydramnios due to premature rupture of membranes. European Journal of Obstetrics & Gynecology and Reproductive Biology 2002;102(2):167‐72.

RevMan 2012 [Computer program]

The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.2. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2012.

Tchirikov 2010

Tchirikov M, Steetskamp J, Hohmann M, Koelbl H. Long‐term amnioinfusion through a subcutaneously implanted amniotic fluid replacement port system for treatment of PPROM in humans. European Journal of Obstetrics & Gynecology and Reproductive Biology 2010;152:30‐3.

Turhan 2002

Turhan NO, Atacan N. Antepartum prophylactic transabdominal amnioinfusion in preterm pregnancies complicated by oligohydramnios. International Journal of Gynecology & Obstetrics 2002;76(1):15‐21.

Van Teeffelen 2013

Van Teeffelen S, Pajkrt E, Willekes C, Van Kuijk SMJ, Mol BWJ. Transabdominal amnioinfusion for improving fetal outcomes after oligohydramnios secondary to preterm prelabour rupture of membranes before 26 weeks. Cochrane Database of Systematic Reviews 2013, Issue 8. [DOI: 10.1002/14651858.CD009952.pub2]

Vergani 1994

Vergani P, Ghidini A, Locatelli A, Cavallone M, Ciarla I, Cappellini A, et al. Risk factors of pulmonary hypoplasia in second trimester premature rupture of membranes. American Journal of Obstetrics and Gynecology 1994;170:1359‐64.

Vergani 1997

Vergani P, Locatelli A, Strobelt N, Mariani S, Cavallone M, Arosio P, et al. Amnioinfusion for prevention of pulmonary hypoplasia in second‐trimester rupture of membranes. American Journal of Perinatology 1997;14(6):325‐9.

Vintzileos 1985

Vintzileos AM, Campbell WA, Nochimson DJ, Weinbaum PJ. Degree of oligohydramnios and pregnancy outcome in patients with premature rupture of membranes. Obstetrics & Gynecology 1985;66(2):162‐7.

References to other published versions of this review

Hofmeyr 1995

Hofmeyr GJ. Amnioinfusion for preterm prelabour rupture of membranes [revised 22 April 1993]. In: Enkin MW, Keirse MJNC, Renfrew MJ, Neilson JP, Crowther C (eds.) Pregnancy and Childbirth Module. In: The Cochrane Database of Systematic Reviews [database on disk and CDROM]. The Cochrane Collaboration; Issue 2, Oxford: Update Software; 1995.

Hofmeyr 1998b

Hofmeyr GJ. Amnioinfusion for preterm rupture of membranes. Cochrane Database of Systematic Reviews 1998, Issue 1. [DOI: 10.1002/14651858.CD000942]

Hofmeyr 2011

Hofmeyr GJ, Essilfie‐Appiah G, Lawrie TA. Amnioinfusion for preterm premature rupture of membranes. Cochrane Database of Systematic Reviews 2011, Issue 12. [DOI: 10.1002/14651858.CD000942.pub2]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Gonzalez 2001

Methods

Randomised trial. Type of randomisation not specified. Abstract only.

Participants

44 pregnant women with gestational ages from 189‐258 days (24 in amnioinfusion group and 20 controls).

Interventions

Amnioinfusion versus no amnioinfusion. Inclusion and exclusion criteria not specified.

Outcomes

Fetal heart rate variability, mode of delivery, cord arterial pH and perinatal morbidity.

Notes

This is an abstract only; we are not aware of any published final results. The abstract results are presented as percentages only without denominators and so could not be used in this review. Amnioinfusion reduced the percentage of caesarean sections done for fetal distress compared with the control group.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not described.

Allocation concealment (selection bias)

Unclear risk

Not described.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not described.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not described.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Abstract only, insufficient detail provided for assessment.

Selective reporting (reporting bias)

Unclear risk

Abstract only, insufficient detail provided for assessment.

Other bias

Unclear risk

Abstract only, insufficient detail provided for assessment.

Nageotte 1985

Methods

'Assigned in a random fashion.'

Participants

Inclusion criteria: spontaneous premature rupture of membranes; gestational age 26 to 35 weeks; decreased or absent amniotic fluid; vertex presentation; no gross fetal anomalies.

Exclusion criteria: premature labour on admission; vaginal bleeding; previous caesarean section and no desire for trial of labour; antepartum fetal distress; consent refused.

1 woman with twin pregnancy and 1 with previous caesarean section were allocated to the amnioinfusion group.

Of 66 women allocated, 3 were excluded for a change from the vertex presentation at the time of labour, and 2 for antepartum fetal distress. Of the remainder, 29 were allocated to amnioinfusion and 32 to the control group.

Interventions

Labour commenced spontaneously, or induced for confirmed fetal pulmonary maturity or infection. All women had fetal scalp electrodes and uterine pressure catheters placed as early in labour as possible. Amnioinfusion with warmed saline at 10 mL per minute for 1 hour (repeated if a large volume of fluid was lost), then 3 mL per minute (total volume infused mean 1160, range 735‐1650 mL); compared with no amnioinfusion.

Caesarean section was performed for persistent late decelerations; recurrent severe variable decelerations; recurrent or uncorrectable prolonged decelerations (no mention of fetal scalp blood sampling).

Outcomes

Amnionitis (2 of the following: fever 38 degrees celsius or more; leucocytosis > 15,000 per microlitre; foul‐smelling amniotic fluid; uterine tenderness); intrapartum fetal heart rate tracings, evaluated in a blinded manner; endometritis (postpartum fever > 38 degrees celsius twice 4 hours apart, and uterine tenderness or foul‐smelling lochia); Apgar scores; umbilical cord arterial and venous pH; neonatal morbidity and mortality.

Notes

Long Beach, California, USA. March 1984 to March 1985.

Of 66 women allocated, 5 (7.6%) were excluded, 3 for a change from the vertex presentation at the time of labour, and 2 for antepartum fetal distress.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not described.

Allocation concealment (selection bias)

Unclear risk

Not described.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not described.

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Fetal heart rate tracings evaluated in a blinded manner.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

5 post‐randomisation exclusions: 3 for non‐vertex presentation and 2 for fetal distress.

Selective reporting (reporting bias)

Unclear risk

Unclear.

Other bias

Unclear risk

Unclear.

Puertas 2007

Methods

Random allocation to 2 groups using a random number table and opaque sealed envelopes.

Participants

Inclusion criteria: women with preterm premature rupture of membranes between 27 and 35 weeks of gestation; included if labour had begun spontaneously or after induction.
Exclusion criteria: women with multiple gestation, presentation other than cephalic, cervical dilatation > 5 cm, cardiotocography signs compatible with non‐reassuring fetal status, meconium‐stained amniotic fluid, umbilical cord prolapse, uterine scarring, placenta praevia, premature detachment of the placenta, any vaginal bleeding of unknown cause, presence of oligohydramnios (amniotic fluid index < 5) prior to premature rupture of the membranes, maternal infection that could be transmitted to the fetus (human immunodeficiency virus and herpes simplex virus), fetal anomalies incompatible with life, or any known obstetric or maternal complication other than premature rupture of membranes.

Interventions

Intrapartum transcervical amnioinfusion versus a control group that had an intrauterine pressure catheter inserted but without amnioinfusion. Physiological saline at 37 degree celsius, at a rate of 600 mL/hr during the first hour. After 1 hour, amniotic fluid index was determined, and if amniotic fluid index was greater than 15, amnioinfusion was stopped. In all other women in the study group amnioinfusion continued at a rate of 180 mL/hr until the cervix was completely dilated. Fetal heart rate and uterine activity were recorded continuously throughout labour. All women who were group B streptococcus carriers received prophylactic intrapartum antibiotics.

Outcomes

Mode of delivery, PH and arterial blood concentrations, neonatal morbidity, puerperal morbidity.

Notes

More group B streptococcal carriers in control group (14 women versus 7 women).

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random number table.

Allocation concealment (selection bias)

Low risk

Opaque sealed envelopes.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not described.

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Partial blinding. Changes in fetal heart rate analysed with the Cabaniss classification by an independent investigator.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Outcome data complete.

Selective reporting (reporting bias)

Low risk

No selective reporting.

Other bias

Unclear risk

More group B streptococcal carriers in control group (14 women versus 7 women).

Singla 2010

Methods

Randomised controlled trial conducted in Delhi, India between August 2005 and 2007.

Participants

60 women with singleton pregnancies (30 in each group) between 26 and 33 + 6 weeks' gestation with amniotic fluid index less than the 5th percentile. Excluded if evidence of chorioamnionitis, placental or fetal anomalies or active labour. Diagnosis of preterm rupture of membranes was made via the litmus paper test and confirmed using ultrasound.

Interventions

Transcervical amnioinfusion with normal saline repeated weekly if amniotic fluid index < 5 versus no amnioinfusion. All women received bed rest, antibiotics and steroids.

Outcomes

Preterm rupture of membranes to delivery interval; neonatal outcome including birthweight, intrapartum fetal distress defined as persistent tachycardia and recurrent, late or severe decelerations; early neonatal sepsis; neonatal mortality; causes of neonatal mortality; mode of delivery; postpartum sepsis.

Notes

No loss to follow‐up. Baseline characteristics were similar between groups. 5 women received amnioinfusion twice, 1 woman received it 3 times.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated random number table.

Allocation concealment (selection bias)

Unclear risk

Not described: "To exclude observer bias, randomisation was performed ....using a computer generated random number table..." There was no mention of allocation concealment (e.g. sealed opaque envelopes).

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not described.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not described.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No loss to follow‐up.

Selective reporting (reporting bias)

Low risk

No selective reporting.

Other bias

Low risk

None other bias was noted.

Tranquilli 2005

Methods

Randomised controlled trial using opaque sealed envelopes and a computer random‐number generator. 44 women met inclusion criteria, 4 refused to participate and 6 delivered before randomisation, leaving 34 women to be randomised.

Participants

Pregnant women included if: singleton pregnancies complicated by preterm premature rupture of membranes, gestational age between 24 and 33 weeks, evidence of preterm premature rupture of membrane within 24 hours of admission, oligohydramnios, absence of uterine contractions at the time of hospitalisation, no placental anomalies or major structural fetal anomalies and normal cardiotocography at the time of admission.

Interventions

17 women were allocated to amnioinfusion and 17 to no amnioinfusion. All women received bedrest and antibiotic prophylaxis and corticosteroid therapy. Prophylactic tocolytic treatment was administered if there were no clinical signs of chorioamnionitis or placental abruption. Women in the treatment group received weekly serial amnioinfusion if the amniotic fluid index fell below the 5th centile and/or a median pocket of amniotic fluid was < 2 cm. The mean volume infused was 250 mL N/saline (range 120‐350 mL), the aim was to restore the amniotic fluid index to > 10th percentile. The amniotic fluid index was measured after the procedure and it was repeated after 24 hours and at least once weekly. If amniotic fluid index was ≤ 5, the amnioinfusion was repeated weekly until 27 weeks of gestation. A non‐stress test was performed daily. Caesarean section was done for chorioamnionitis and fetal distress (defined as persistent tachycardia with reduced variability, recurrent late or severe variable decelerations).

Outcomes

Birthweight; admission to neonatal intensive care unit; gestational age at delivery (weeks); pulmonary hypoplasia diagnosed on the basis of strict clinical and radiological criteria at 1 and 3 months after delivery; abnormal neurological outcomes. The preterm premature rupture of membrane‐delivery interval was also determined.

Notes

Study conducted at the Salesi Mothers' and Children's Hospital, Ancona, Italy, from January‐December 2002.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated.

Allocation concealment (selection bias)

Low risk

Opaque sealed envelopes.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not described.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not described.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Outcome data were complete.

Selective reporting (reporting bias)

Unclear risk

Authors do not report mode of delivery, Apgar scores or cord arterial pH.

Other bias

Low risk

No other bias noted.

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

De Santis 2003

The quality of the randomisation process was poor. Women were by chance admitted into 1 of the 2 divisions of the department of obstetrics and gynaecology. Among the 71 women who were included in the study, 37 underwent serial amnioinfusion and 34 were used as controls. Also included in the study were women who underwent preterm rupture of membrane after amniocentesis for prenatal diagnosis. 10 patients (27.0%) in the amnioinfusion group and 8 patients (23.5%) in the control group. The study is also limited by the long period in which it was performed due to the low prevalence of this disease. The control group was selected without proper randomisation therefore bias could not be excluded during the selection process.

Gowri 2004

Randomised controlled trial of amnioinfusion versus no amnioinfusion for oligohydramnios. Small numbers (9 controls versus 8 study participants), only 3 study participants who received amnioinfusion had premature rupture of membranes and these outcome data were not extractable from totals.

Locatelli 2000

The study was not a randomised controlled trial. All singleton pregnancies with preterm premature rupture of membranes at < 26 weeks' gestation and lasting > 4 days between January 1991 and June 1998 were included. Consenting women with persistent (> 4 days) oligohydramnios (maximum cord‐free pocket of amniotic fluid volume less or equal to 2 cm) received serial transabdominal amnioinfusions to maintain an amniotic pocket > 2 cm. The pregnancy, neonatal, and long‐term neurological outcomes of the cases that spontaneously maintained a median amniotic fluid pocket > 2 cm (amnioinfusion‐not‐necessary group) were compared with those of women with oligohydramnios who underwent amnioinfusion but continued to have a median amniotic fluid pocket after preterm premature rupture of membranes (amniotic fluid pocket less or equal to 2 cm/persistent oligohydramnios group) and with those of women in whom oligohydramnios was alleviated by amnioinfusion for at least 48 hours (successful amnioinfusion group).

The study also incorporated 18 cases that had been previously reported in Vergani 1997.

Mino 1999

Study population were women with ruptured membranes at term, not preterm.

Roberts: AMIPROM

Excluded because even though this is a randomised controlled trial involving preterm premature rupture of membrane and amnioinfusion, the gestational ages when the preterm premature rupture of membrane occurred were in the 2nd trimester of pregnancy. There are no reported data for 3rd trimester outcomes. This was a prospective non‐blinded randomised controlled trial with randomisation stratified for pregnancies where the membranes ruptured between 16 + 0 and 19 + 6 weeks' gestation and 20 + 0 and 23 + 6 weeks' gestation to minimise the risk of random imbalance in gestational age distribution between randomised groups. This study was carried out in 4 UK hospital‐based Fetal Medicine Units (Liverpool Women’s NHS Trust, St. Mary’s Hospital Manchester, Birmingham Women’s NHS Foundation Trust, Wirral University Hospitals Trust). Participants were randomly allocated to either serial weekly trans‐abdominal amnioinfusions if the deepest pool of amniotic fluid was < 2 cm or expectant management until 37 weeks of pregnancy. Short‐term maternal, pregnancy and neonatal and long‐term outcomes for the child were studied. Long‐term respiratory morbidity was assessed using validated respiratory questionnaires at 6, 12 and 18 months of age and infant lung function test at around 12 months of age. Neurodevelopment was assessed using Bayley’s Scale of Infant Development II at corrected age of 2.

Vergani 2007

Excluded because even though this is an randomised controlled trial involving preterm premature rupture of membrane and amnioinfusion, the gestational ages to be considered are preterm premature rupture of membranes that occurred in the 2nd trimester of pregnancy (< 24 weeks). The study will consider singleton pregnancies, early spontaneous preterm premature rupture of membrane < 24.3 weeks, oligohydramnios (deepest vertical pocket < 2 cm) for at least 4 days and no longer than 15 days at enrolment. The study is open and will be run through a dedicated password protected website, and with a minimal number of outcome measures. Primary outcomes include survival until discharge from the neonatal intensive care unit, while secondary outcomes include latency time from preterm premature rupture of membrane to delivery, gestational age at birth, indication for delivery, number of days of ventilatory support, serious neurologic morbidity, neonatal sepsis prevalence, need for oxygen at 36 weeks post‐conception. Statistics: 38 patients in each arm are necessary to show an increase in neonatal survival from 10% to 40%, with a power of 0.80 and alpha = 0.05. An interim analysis after recruitment of 75% of the study population will be held in order to re‐calculate sample size according to the difference between the groups in latency time as the main secondary outcome.

Data and analyses

Open in table viewer
Comparison 1. Transcervical amnioinfusion for preterm rupture of membranes

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Persistant variable decelerations Show forest plot

1

86

Risk Ratio (M‐H, Fixed, 95% CI)

0.52 [0.30, 0.91]

Analysis 1.1

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 1 Persistant variable decelerations.

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 1 Persistant variable decelerations.

2 Severe variable decelerations per hour in first stage Show forest plot

1

61

Mean Difference (IV, Fixed, 95% CI)

‐1.2 [‐1.83, ‐0.57]

Analysis 1.2

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 2 Severe variable decelerations per hour in first stage.

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 2 Severe variable decelerations per hour in first stage.

3 Caesarean section Show forest plot

2

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

Analysis 1.3

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 3 Caesarean section.

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 3 Caesarean section.

3.1 Caesarean section overall

2

147

Risk Ratio (M‐H, Random, 95% CI)

0.65 [0.25, 1.73]

3.2 Caesarean section for fetal distress

1

86

Risk Ratio (M‐H, Random, 95% CI)

0.43 [0.12, 1.55]

4 Forceps/vacuum assisted delivery Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 1.4

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 4 Forceps/vacuum assisted delivery.

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 4 Forceps/vacuum assisted delivery.

4.1 Overall

1

86

Risk Ratio (M‐H, Fixed, 95% CI)

1.2 [0.58, 2.48]

4.2 For fetal distress

1

86

Risk Ratio (M‐H, Fixed, 95% CI)

0.11 [0.01, 2.00]

5 1 minute Apgar score < 4 Show forest plot

1

61

Risk Ratio (M‐H, Fixed, 95% CI)

0.28 [0.03, 2.33]

Analysis 1.5

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 5 1 minute Apgar score < 4.

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 5 1 minute Apgar score < 4.

6 Umbilical arterial pH Show forest plot

1

61

Mean Difference (IV, Fixed, 95% CI)

0.11 [0.08, 0.14]

Analysis 1.6

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 6 Umbilical arterial pH.

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 6 Umbilical arterial pH.

7 Umbilical pH ≤ 7.20 Show forest plot

1

86

Risk Ratio (M‐H, Fixed, 95% CI)

0.25 [0.06, 1.11]

Analysis 1.7

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 7 Umbilical pH ≤ 7.20.

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 7 Umbilical pH ≤ 7.20.

8 Neonatal morbidity Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 1.8

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 8 Neonatal morbidity.

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 8 Neonatal morbidity.

8.1 Overall

1

86

Risk Ratio (M‐H, Fixed, 95% CI)

0.5 [0.19, 1.34]

9 Neonatal death Show forest plot

1

61

Risk Ratio (M‐H, Fixed, 95% CI)

0.55 [0.05, 5.77]

Analysis 1.9

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 9 Neonatal death.

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 9 Neonatal death.

10 Maternal puerperal sepsis Show forest plot

2

147

Risk Ratio (M‐H, Fixed, 95% CI)

0.36 [0.06, 2.18]

Analysis 1.10

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 10 Maternal puerperal sepsis.

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 10 Maternal puerperal sepsis.

Open in table viewer
Comparison 2. Transabdominal amnioinfusion for preterm rupture of membranes

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Fetal distress Show forest plot

1

60

Risk Ratio (M‐H, Fixed, 95% CI)

0.27 [0.08, 0.88]

Analysis 2.1

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 1 Fetal distress.

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 1 Fetal distress.

2 Gestational age at delivery (weeks) Show forest plot

2

94

Mean Difference (IV, Random, 95% CI)

‐0.49 [‐2.63, 1.65]

Analysis 2.2

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 2 Gestational age at delivery (weeks).

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 2 Gestational age at delivery (weeks).

3 Neonatal morbidity Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 2.3

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 3 Neonatal morbidity.

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 3 Neonatal morbidity.

3.1 Neonatal sepsis/infection

1

60

Risk Ratio (M‐H, Fixed, 95% CI)

0.26 [0.11, 0.61]

3.2 Pulmonary hypoplasia

1

34

Risk Ratio (M‐H, Fixed, 95% CI)

0.22 [0.06, 0.88]

3.3 Abnormal neurological outcome

1

34

Risk Ratio (M‐H, Fixed, 95% CI)

0.25 [0.03, 2.01]

4 Delivery within 7 days Show forest plot

1

34

Risk Ratio (M‐H, Fixed, 95% CI)

0.18 [0.05, 0.70]

Analysis 2.4

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 4 Delivery within 7 days.

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 4 Delivery within 7 days.

5 Time to delivery (days) Show forest plot

1

60

Mean Difference (IV, Fixed, 95% CI)

0.57 [‐2.86, 4.00]

Analysis 2.5

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 5 Time to delivery (days).

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 5 Time to delivery (days).

6 Admission to neonatal intensive care unit Show forest plot

1

34

Risk Ratio (M‐H, Fixed, 95% CI)

1.0 [0.90, 1.12]

Analysis 2.6

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 6 Admission to neonatal intensive care unit.

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 6 Admission to neonatal intensive care unit.

7 Neonatal death Show forest plot

2

94

Risk Ratio (M‐H, Fixed, 95% CI)

0.3 [0.14, 0.66]

Analysis 2.7

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 7 Neonatal death.

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 7 Neonatal death.

8 Birthweight (grams) Show forest plot

2

94

Mean Difference (IV, Random, 95% CI)

15.65 [‐254.02, 285.32]

Analysis 2.8

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 8 Birthweight (grams).

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 8 Birthweight (grams).

9 Maternal puerperal sepsis Show forest plot

1

60

Risk Ratio (M‐H, Fixed, 95% CI)

0.2 [0.05, 0.84]

Analysis 2.9

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 9 Maternal puerperal sepsis.

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 9 Maternal puerperal sepsis.

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 1

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 2

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 1 Persistant variable decelerations.
Figuras y tablas -
Analysis 1.1

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 1 Persistant variable decelerations.

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 2 Severe variable decelerations per hour in first stage.
Figuras y tablas -
Analysis 1.2

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 2 Severe variable decelerations per hour in first stage.

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 3 Caesarean section.
Figuras y tablas -
Analysis 1.3

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 3 Caesarean section.

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 4 Forceps/vacuum assisted delivery.
Figuras y tablas -
Analysis 1.4

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 4 Forceps/vacuum assisted delivery.

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 5 1 minute Apgar score < 4.
Figuras y tablas -
Analysis 1.5

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 5 1 minute Apgar score < 4.

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 6 Umbilical arterial pH.
Figuras y tablas -
Analysis 1.6

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 6 Umbilical arterial pH.

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 7 Umbilical pH ≤ 7.20.
Figuras y tablas -
Analysis 1.7

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 7 Umbilical pH ≤ 7.20.

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 8 Neonatal morbidity.
Figuras y tablas -
Analysis 1.8

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 8 Neonatal morbidity.

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 9 Neonatal death.
Figuras y tablas -
Analysis 1.9

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 9 Neonatal death.

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 10 Maternal puerperal sepsis.
Figuras y tablas -
Analysis 1.10

Comparison 1 Transcervical amnioinfusion for preterm rupture of membranes, Outcome 10 Maternal puerperal sepsis.

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 1 Fetal distress.
Figuras y tablas -
Analysis 2.1

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 1 Fetal distress.

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 2 Gestational age at delivery (weeks).
Figuras y tablas -
Analysis 2.2

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 2 Gestational age at delivery (weeks).

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 3 Neonatal morbidity.
Figuras y tablas -
Analysis 2.3

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 3 Neonatal morbidity.

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 4 Delivery within 7 days.
Figuras y tablas -
Analysis 2.4

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 4 Delivery within 7 days.

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 5 Time to delivery (days).
Figuras y tablas -
Analysis 2.5

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 5 Time to delivery (days).

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 6 Admission to neonatal intensive care unit.
Figuras y tablas -
Analysis 2.6

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 6 Admission to neonatal intensive care unit.

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 7 Neonatal death.
Figuras y tablas -
Analysis 2.7

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 7 Neonatal death.

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 8 Birthweight (grams).
Figuras y tablas -
Analysis 2.8

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 8 Birthweight (grams).

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 9 Maternal puerperal sepsis.
Figuras y tablas -
Analysis 2.9

Comparison 2 Transabdominal amnioinfusion for preterm rupture of membranes, Outcome 9 Maternal puerperal sepsis.

Transabdominal amnioinfusion compared with no amnioinfusion for preterm rupture of membranes (PROM)

Patient or population: pregnant women with PROM

Settings: hospital

Intervention: transabdominal amnioinfusion

Comparison: no amnioinfusion

Outcomes

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Neonatal death

RR 0.30 (0.14 ‐ 0.66)

94 (two studies)

⊕⊕⊕⊝
moderate

Risk of neonatal death in the amnioinfusion group was 127 per 1000 compared to 426 per 1000 in the control group.

Neonatal sepsis/infection

RR 0.26 (0.11 ‐ 0.61)

60 (one study*)

⊕⊕⊕⊝
moderate

*Sepsis defined as micro‐erythrocyte sedimentation rate > 5 mm, total leucocyte count < 5000, CRP > 6 mg/dL, platelet count < 100,000 or a positive blood culture within the first 48 hours.

Pulmonary hypoplasia

RR 0.22 (0.06 ‐ 0.88)

34 (one study)

⊕⊕⊝⊝
low

Pulmonary hypoplasia was diagnosed according to strict clinical and radiological criteria, however, this study was small and blinding to group allocation was not described and so we downgraded this evidence from moderate to low. More evidence is needed.

Maternal puerperal sepsis

RR 0.20 (0.05 ‐ 0.84)

60 (one study**)

⊕⊕⊕⊝
moderate

**Defined as fever > 38° C and a positive high vaginal swab culture.

GRADE Working Group grades of evidence
High quality: further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: we are very uncertain about the estimate.

CI: confidence interval; CRP: C‐reactive protein; RR: risk ratio

Figuras y tablas -
Comparison 1. Transcervical amnioinfusion for preterm rupture of membranes

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Persistant variable decelerations Show forest plot

1

86

Risk Ratio (M‐H, Fixed, 95% CI)

0.52 [0.30, 0.91]

2 Severe variable decelerations per hour in first stage Show forest plot

1

61

Mean Difference (IV, Fixed, 95% CI)

‐1.2 [‐1.83, ‐0.57]

3 Caesarean section Show forest plot

2

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

3.1 Caesarean section overall

2

147

Risk Ratio (M‐H, Random, 95% CI)

0.65 [0.25, 1.73]

3.2 Caesarean section for fetal distress

1

86

Risk Ratio (M‐H, Random, 95% CI)

0.43 [0.12, 1.55]

4 Forceps/vacuum assisted delivery Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

4.1 Overall

1

86

Risk Ratio (M‐H, Fixed, 95% CI)

1.2 [0.58, 2.48]

4.2 For fetal distress

1

86

Risk Ratio (M‐H, Fixed, 95% CI)

0.11 [0.01, 2.00]

5 1 minute Apgar score < 4 Show forest plot

1

61

Risk Ratio (M‐H, Fixed, 95% CI)

0.28 [0.03, 2.33]

6 Umbilical arterial pH Show forest plot

1

61

Mean Difference (IV, Fixed, 95% CI)

0.11 [0.08, 0.14]

7 Umbilical pH ≤ 7.20 Show forest plot

1

86

Risk Ratio (M‐H, Fixed, 95% CI)

0.25 [0.06, 1.11]

8 Neonatal morbidity Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

8.1 Overall

1

86

Risk Ratio (M‐H, Fixed, 95% CI)

0.5 [0.19, 1.34]

9 Neonatal death Show forest plot

1

61

Risk Ratio (M‐H, Fixed, 95% CI)

0.55 [0.05, 5.77]

10 Maternal puerperal sepsis Show forest plot

2

147

Risk Ratio (M‐H, Fixed, 95% CI)

0.36 [0.06, 2.18]

Figuras y tablas -
Comparison 1. Transcervical amnioinfusion for preterm rupture of membranes
Comparison 2. Transabdominal amnioinfusion for preterm rupture of membranes

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Fetal distress Show forest plot

1

60

Risk Ratio (M‐H, Fixed, 95% CI)

0.27 [0.08, 0.88]

2 Gestational age at delivery (weeks) Show forest plot

2

94

Mean Difference (IV, Random, 95% CI)

‐0.49 [‐2.63, 1.65]

3 Neonatal morbidity Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

3.1 Neonatal sepsis/infection

1

60

Risk Ratio (M‐H, Fixed, 95% CI)

0.26 [0.11, 0.61]

3.2 Pulmonary hypoplasia

1

34

Risk Ratio (M‐H, Fixed, 95% CI)

0.22 [0.06, 0.88]

3.3 Abnormal neurological outcome

1

34

Risk Ratio (M‐H, Fixed, 95% CI)

0.25 [0.03, 2.01]

4 Delivery within 7 days Show forest plot

1

34

Risk Ratio (M‐H, Fixed, 95% CI)

0.18 [0.05, 0.70]

5 Time to delivery (days) Show forest plot

1

60

Mean Difference (IV, Fixed, 95% CI)

0.57 [‐2.86, 4.00]

6 Admission to neonatal intensive care unit Show forest plot

1

34

Risk Ratio (M‐H, Fixed, 95% CI)

1.0 [0.90, 1.12]

7 Neonatal death Show forest plot

2

94

Risk Ratio (M‐H, Fixed, 95% CI)

0.3 [0.14, 0.66]

8 Birthweight (grams) Show forest plot

2

94

Mean Difference (IV, Random, 95% CI)

15.65 [‐254.02, 285.32]

9 Maternal puerperal sepsis Show forest plot

1

60

Risk Ratio (M‐H, Fixed, 95% CI)

0.2 [0.05, 0.84]

Figuras y tablas -
Comparison 2. Transabdominal amnioinfusion for preterm rupture of membranes