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Profilaxis con betamiméticos orales para la prevención del trabajo de parto prematuro en embarazos de un feto único

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Referencias

Referencias de los estudios incluidos en esta revisión

Ir a:

Mathews 1967 {published data only}

Mathews DD, Friend JB, Michael CA. A double‐blind trial of oral isoxuprine in the prevention of premature labour. Journal of Obstetrics and Gynaecology of the British Commonwealth 1967;74:68‐70.

Referencias de los estudios excluidos de esta revisión

Ir a:

Alexander 1986 {published data only}

Alexander S, Yudkin P. Betamimetic drugs in the prophylaxis of preterm labour: extent and rationale of their use. British Journal of Obstetrics and Gynaecology 1986;93:891‐2.

Allen 1965 {published data only}

Allen H, Short H, Fraleigh D. The use of isoxsuprine in the management of preterm labour. Applied Therapeutics 1965;7:544‐7.

Briscoe 1966 {published data only}

Briscoe CC. Failure of oral isoxsuprine to prevent prematurity. American Journal of Obstetrics and Gynecology 1966;95:885‐6.

Hallak 1993 {published data only}

Hallak M, Moise KJ, Lira N, Dorman K, O'Brian Smith E, Cotton DB. The effect of tocolytic agents (indomethacin and terbutaline) on fetal breathing (FBM) and body movements (FM): a prospective, randomized, double blind, placebo‐controlled clinical trial. American Journal of Obstetrics and Gynecology 1992;166:375.
Hallak M, Moise KJ, Lira N, Dorman KF, O'Brian Smith E, Cotton DB. The effect of tocolytic agents (indomethacin and terbutaline) on fetal breathing and body movements: a prospective, randomized, double‐blind, placebo‐controlled clinical trial. American Journal of Obstetrics and Gynecology 1992;167:1059‐63.
Hallak M, Moise KJ, O'Brian Smith E, Cotton DB. The effects of indomethacin and terbutaline on human fetal umbilical artery velocimetry: a randomized double‐blind study. American Journal of Obstetrics and Gynecology 1993;168:348.
Hallak M, Moise KJ, O'Brian Smith E, Cotton DB. The effects of indomethacin and terbutaline on human fetal umbilical artery velocimetry: a randomized, double‐blind study. American Journal of Obstetrics and Gynecology 1993;168:865‐8.

Hendricks 1961 {published data only}

Hendricks C, Cibils L, Pose S, Eskes T. The pharmacologic control of excessive uterine activity with isoxsuprine. American Journal of Obstetrics and Gynecology 1961;82(5):1064‐78.

Matijevic 2006a {published data only}

Matijevic R, Grgic O, Vasilj O. Ritodrine in oral maintenance of tocolysis after active preterm labor: randomized controlled trial. Croatian Medical Journal 2006;47:25‐31.

Walters 1977 {published data only}

Walters WAW, Wood C. A trial of oral ritodrine for the prevention of premature labour. British Journal of Obstetrics and Gynaecology 1977;84:26‐30.

Referencias adicionales

Ir a:

Althuisius 1998

Althuisius S, Dekker G, Hummel P, Bekedam D, Kuik D, Van Giejn HP. Cervical incompetence prevention randomisation cerclage trial (CIPRACT); effect of therapeutic cerclage with bed rest v bed rest only on cervical length. Ultrasound in Obstetrics & Gynecology 1998;12:312‐7.

Anotayanonth 2004

Anotayanonth S, Subhedar NV, Neilson JP, Harigopal S. Betamimetics for inhibiting preterm labour. Cochrane Database of Systematic Reviews 2004, Issue 4. [Art. No.: CD004352. DOI: 10.1002/14651858.CD004352.pub2]

Barden 1980

Barden TP. Ritodrine hydrochloride: an FDA‐approved tocolytic agent for use in the United States. Part I. Pharmacology, clinical history, administration, side effects and safety. Obstetrics & Gynecology 1980;56:1‐6.

Bell 1978

Bell MJ, Ternberg JL, Feigin RD, Keating JP, Marshall R, Barton L, et al. Neonatal necrotizing enterocolitis. Therapeutic decisions based upon clinical staging. Annals of Surgery 1978;187(1):1‐7.

Bienstock 2001

Bienstock JL, Ural SH, Blakemore K, Pressman EK. University hospital‐based prenatal care decreases rate of preterm delivery and costs, when compared to managed care. Journal of Maternal‐Fetal Medicine 2001;10(2):127‐30.

Bracci 2006

Bracci R, Perrone S, Buonocore G. The timing of neonatal brain damage. Biology of the Neonate 2006;90(3):145‐55.

Costeloe 2000

Costeloe K, Hennessy E, Gibson AT, Marlow N, Wilkinson AR. The EPICure study: outcomes to discharge from hospital for infants born at the threshold of viability. Pediatrics 2000;106(4):659‐71.

da Fonseca 2003

da Fonseca EB, Bittar RE, Carvalho MHB, Zugaib M. Prophylactic administration of progesterone by vaginal suppository to reduce the incidence of spontaneous preterm birth in women at increased risk: a randomized placebo‐controlled double‐blind study. American Journal of Obstetrics and Gynecology 2003;188(2):419‐24.

Dodd 2006

Dodd JM, Crowther CA, Dare MR, Middleton P. Oral betamimetics for maintenance therapy after threatened preterm labour. Cochrane Database of Systematic Reviews 2006, Issue 1. [DOI: 10.1002/14651858.CD003927.pub2]

Gabor 1982

Gabor H, James MR. Biochemistry and pharmacology of the myometrium and labor: regulation at the cellular and molecular levels. American Journal of Obstetrics and Gynecology 1982;142:225‐37.

Gyetvai 1999

Gyetvai K, Hannah ME, Hodnett ED, Ohlsson A. Tocolytics for preterm labor: a systematic review. Obstetrics & Gynecology 1999;94:869‐77.

Hack 1999

Hack M. Consideration of the use of health status, functional outcome, and quality‐of‐life to monitor neonatal intensive care practice. Pediatrics 1999;103(1 Suppl E):319‐28.

Higgins 2005

Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions 4.2.4 [updated March 2005]. In: The Cochrane Library, Issue 2, 2005. Chichester, UK: John Wiley & Sons, Ltd.

Hoffman 1984

Hoffman HJ, Bakketeig lS. Risk factors associated with the occurrence of preterm birth. Clinical Obstetrics and Gynecology 1984;27(3):539‐52.

ICROP 1984

Anonymous. An international classification of retinopathy of prematurity. The committee for the classification of retinopathy of prematurity. Archives of Ophthalmology 1984;102(8):1130‐4.

Kramer 2000

Kramer M, Demissie K, Yang H, Platt RW, Sauve R, Liston R. The contribution of mild and moderate preterm birth to infant mortality. JAMA 2000;284:843‐9.

Liggins 1972

Liggins GC, Howie RN. A controlled trial of antepartum glucocorticoid treatment for prevention of the respiratory distress syndrome in premature infants. Pediatrics 1972;50(4):515‐25.

Lumley 2003

Lumley J. Defining the problem: epidemiology of preterm birth. BJOG: an international journal of obstetrics and gynaecology 2003;110(Suppl 20):3‐7.

Meis 2003

Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, Moawad AH, et al. Prevention of recurrent preterm delivery by 17 alpha‐hydroxyprogesterone caproate. New England Journal of Medicine 2003;384(24):2379‐85.

Papile 1978

Papile LA, Burstein J, Burstein R, Koffler H. Incidence and evolution of subependymal and intraventricular hemorrhage: a study of infants with birth weights less than 1,500 gm. Journal of Pediatrics 1978;92(4):529‐34.

Petrou 2001

Petrou S, Sach T, Davidson L. The long‐term costs of preterm birth and low birth weight: results of a systematic review. Child Care, Health and Development 2001;27:97‐115.

RevMan 2003 [Computer program]

The Cochrane Collaboration. Review Manager (RevMan). Version 4.2 for Windows. Oxford, England: The Cochrane Collaboration, 2003.

Sciscione 2003

Sciscione AC, Ivester T, Largoza M, Manley J, Shlossman P, Colmogen GHC. Acute pulmonary edema in pregnancy. Obstetrics & Gynecology 2003;101:511‐5.

Sosa 2004

Sosa C, Althabe F, Belizán J, Bergel E. Bed rest in singleton pregnancies for preventing preterm birth. Cochrane Database of Systematic Reviews 2004, Issue 1. [Art. No.: CD003581. DOI: 10.1002/14651858.CD003581.pub2]

Ugwumadu 2003

Ugwumadu A, Manyonda I, Reid F, Hay P. Effect of early oral clindamycin on late miscarriage and preterm delivery in asymptomatic women with abnormal vaginal flora and bacterial vaginosis: a randomised controlled trial. Lancet 2003;361:983‐8.

Wood 2005

Wood NS, Costeloe K, Gibson AT, Hennessy EM, Marlow N, Wilkinson AR, EPICure Study Group. The EPICure study: associations and antecedents of neurological and developmental disability at 30 months of age following extremely preterm birth. Archives of Disease in Childhood. Fetal and Neonatal Edition 2005;90(2):F134‐F140.

Yamasmit 2005

Yamasmit W, Chaithongwongwatthana S, Tolosa JE, Limpongsanurak S, Pereira L, Lumbiganon P. Prophylactic oral betamimetics for reducing preterm birth in women with a twin pregnancy. Cochrane Database of Systematic Reviews 2005, Issue 3. [Art. No.: CD004733. DOI: 10.1002/14651858.CD004733.pub2]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Ir a:

Mathews 1967

Methods

Performance bias: blinding of participants ‐ yes; blinding of caregiver ‐ yes; blinding of outcome assessment ‐ yes.
Attrition bias: 15.6% of participants discontinued medication.
Completeness of follow up: yes.

Participants

Country: UK.
Number: 31 women in the intervention group, 33 women in the control group.
Gestational age at trial entry: between 28 and 32 weeks.

Interventions

Isoxsuprine 30 mg 4 times a day versus placebo.

Outcomes

Incidence of:
‐ birth less than 36 weeks;
‐ neonatal mortality;
‐ birthweight less than 2500 grams.
Mean gestational age.
Mean birthweight.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Unclear risk

B ‐ Unclear

Characteristics of excluded studies [ordered by study ID]

Ir a:

Study

Reason for exclusion

Alexander 1986

Comparison of preterm delivery rates of asthmatic women routinely taking betamimetics and those on no betamimetics. Observational study not a RCT.

Allen 1965

Trial of isoxsuprine to inhibit acute preterm labour.

Briscoe 1966

Trial tested the effects of oral isoxsuprine in preventing preterm labour in low‐risk women.

Hallak 1993

Trial of the effect of betamimetics on fetal umbilical artery velocimetry in low‐risk pregnancy.

Hendricks 1961

Trial of the effect of isoxsuprine on uterine contractions in women in normal and preterm labour. Observational study not a RCT.

Matijevic 2006a

Trial of maintenance tocolytic therapy.

Walters 1977

Trial comparing the effects of oral ritodrine and placebo on preterm delivery rates of primigravid women in whom the internal os of the cervix was one or more fingerbreadths dilated at 28 to 32 weeks' gestation. Whilst cervical change on digital examination was thought at the time this study was conducted to be an accurate predictor of preterm delivery subsequent work has shown that routine digital examination, which is a subjective and non‐specific examination, has a poor positive predictive value and may influence the number of unnecessary hospital admissions or tocolytic use.

RCT: randomised controlled trial

Data and analyses

Open in table viewer
Comparison 1. Betamimetic versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Perinatal mortality Show forest plot

1

64

Odds Ratio (M‐H, Fixed, 95% CI)

4.74 [0.50, 45.00]
Analysis 1.1
Comparison 1 Betamimetic versus placebo, Outcome 1 Perinatal mortality.

Comparison 1 Betamimetic versus placebo, Outcome 1 Perinatal mortality.

2 Preterm labour Show forest plot

1

64

Odds Ratio (M‐H, Fixed, 95% CI)

1.07 [0.14, 8.09]
Analysis 1.2
Comparison 1 Betamimetic versus placebo, Outcome 2 Preterm labour.

Comparison 1 Betamimetic versus placebo, Outcome 2 Preterm labour.

3 Side effects sufficient to stop therapy Show forest plot

1

64

Odds Ratio (M‐H, Fixed, 95% CI)

2.51 [0.59, 10.76]
Analysis 1.3
Comparison 1 Betamimetic versus placebo, Outcome 3 Side effects sufficient to stop therapy.

Comparison 1 Betamimetic versus placebo, Outcome 3 Side effects sufficient to stop therapy.

4 Birth before 37 completed weeks Show forest plot

1

64

Odds Ratio (M‐H, Fixed, 95% CI)

1.07 [0.14, 8.09]
Analysis 1.4
Comparison 1 Betamimetic versus placebo, Outcome 4 Birth before 37 completed weeks.

Comparison 1 Betamimetic versus placebo, Outcome 4 Birth before 37 completed weeks.

5 Birthweight less than 2500 grams Show forest plot

1

64

Odds Ratio (M‐H, Fixed, 95% CI)

1.74 [0.44, 6.87]
Analysis 1.5
Comparison 1 Betamimetic versus placebo, Outcome 5 Birthweight less than 2500 grams.

Comparison 1 Betamimetic versus placebo, Outcome 5 Birthweight less than 2500 grams.

6 Neonatal death Show forest plot

1

64

Odds Ratio (M‐H, Fixed, 95% CI)

4.74 [0.50, 45.00]
Analysis 1.6
Comparison 1 Betamimetic versus placebo, Outcome 6 Neonatal death.

Comparison 1 Betamimetic versus placebo, Outcome 6 Neonatal death.

7 Side effects and adverse effects of betamimetics not sufficient to stop medication Show forest plot

1

64

Odds Ratio (M‐H, Fixed, 95% CI)

2.5 [0.88, 7.08]
Analysis 1.7
Comparison 1 Betamimetic versus placebo, Outcome 7 Side effects and adverse effects of betamimetics not sufficient to stop medication.

Comparison 1 Betamimetic versus placebo, Outcome 7 Side effects and adverse effects of betamimetics not sufficient to stop medication.

Comparison 1 Betamimetic versus placebo, Outcome 1 Perinatal mortality.
Figuras y tablas -
Analysis 1.1

Comparison 1 Betamimetic versus placebo, Outcome 1 Perinatal mortality.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Comparison 1 Betamimetic versus placebo, Outcome 2 Preterm labour.
Figuras y tablas -
Analysis 1.2

Comparison 1 Betamimetic versus placebo, Outcome 2 Preterm labour.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Comparison 1 Betamimetic versus placebo, Outcome 3 Side effects sufficient to stop therapy.
Figuras y tablas -
Analysis 1.3

Comparison 1 Betamimetic versus placebo, Outcome 3 Side effects sufficient to stop therapy.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Comparison 1 Betamimetic versus placebo, Outcome 4 Birth before 37 completed weeks.
Figuras y tablas -
Analysis 1.4

Comparison 1 Betamimetic versus placebo, Outcome 4 Birth before 37 completed weeks.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Comparison 1 Betamimetic versus placebo, Outcome 5 Birthweight less than 2500 grams.
Figuras y tablas -
Analysis 1.5

Comparison 1 Betamimetic versus placebo, Outcome 5 Birthweight less than 2500 grams.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Comparison 1 Betamimetic versus placebo, Outcome 6 Neonatal death.
Figuras y tablas -
Analysis 1.6

Comparison 1 Betamimetic versus placebo, Outcome 6 Neonatal death.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Comparison 1 Betamimetic versus placebo, Outcome 7 Side effects and adverse effects of betamimetics not sufficient to stop medication.
Figuras y tablas -
Analysis 1.7

Comparison 1 Betamimetic versus placebo, Outcome 7 Side effects and adverse effects of betamimetics not sufficient to stop medication.

Ir a la figura de la revisiónAbrir en una pestaña nueva
Comparison 1. Betamimetic versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Perinatal mortality Show forest plot

1

64

Odds Ratio (M‐H, Fixed, 95% CI)

4.74 [0.50, 45.00]

2 Preterm labour Show forest plot

1

64

Odds Ratio (M‐H, Fixed, 95% CI)

1.07 [0.14, 8.09]

3 Side effects sufficient to stop therapy Show forest plot

1

64

Odds Ratio (M‐H, Fixed, 95% CI)

2.51 [0.59, 10.76]

4 Birth before 37 completed weeks Show forest plot

1

64

Odds Ratio (M‐H, Fixed, 95% CI)

1.07 [0.14, 8.09]

5 Birthweight less than 2500 grams Show forest plot

1

64

Odds Ratio (M‐H, Fixed, 95% CI)

1.74 [0.44, 6.87]

6 Neonatal death Show forest plot

1

64

Odds Ratio (M‐H, Fixed, 95% CI)

4.74 [0.50, 45.00]

7 Side effects and adverse effects of betamimetics not sufficient to stop medication Show forest plot

1

64

Odds Ratio (M‐H, Fixed, 95% CI)

2.5 [0.88, 7.08]
Figuras y tablas -
Comparison 1. Betamimetic versus placebo
Ir a la tabla de la revisión