Methods

Randomised clinical trial. Randomisation method was not explained.

Participants

152 pregnant women admitted for delivery. The characteristics of participating women are not described.

Interventions

Women were randomly allocated to receive either standardised enema soap solution within 30 minutes of enrolment or no enema (75 women to enema and 77 to no enema).

Outcomes

The primary outcome was time interval from enrolment to delivery. Secondary outcomes included intrapartum infection rate, faecal soiling at delivery, mode of delivery and patient satisfaction.

Notes

Abstract publication.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not reported.

Allocation concealment (selection bias)

Unclear risk

Not reported.

Blinding (performance bias and detection bias)
All outcomes

High risk

Not done.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

There are some missing data in outcomes' results. Women's satisfaction and neonatal outcomes were not reported. No standard deviation was provided

Selective reporting (reporting bias)

Unclear risk

Protocol of the study is not available.

Other bias

Unclear risk

Declarations of interest are not declared. No information was provided concerning baseline demographics

Methods

Randomised clinical trial. Block randomisations in blocks of 2 (20%), 4 (60%) and 6 (20%) using sealed envelopes when participants visited the obstetrics admission ward and filled inclusion criteria.

Participants

Women attending a tertiary care hospital in Bogota, Colombia for delivery. Inclusion criteria included: living and staying in Bogota the month following delivery; gestational age of 36 or more weeks; willingness to participate. Exclusion criteria: medical emergency; use of antibiotics the week prior to admission; rupture of amniotic membranes; cervical dilatation over 7 cm.

Interventions

High volume (1000 mL) saline solution enema or no enema.

Outcomes

Participants and newborns were followed for 1 month after delivery. Visits were carried out at the puerperium and paediatrics ward and neonatal intensive care unit. Participants were evaluated through telephone interviews and/or physical examination carried out 1 and 4 weeks after delivery. 24‐hour pager service was offered to inform of any health problems. Telephone follow‐up was performed when patients failed to attend programmed visits. Infections were diagnosed on clinical grounds. Neonatal infections included: ocular, umbilical or skin infection; lower or upper respiratory tract infection; intestinal infection; meningitis or sepsis. Puerperal infections included: dehiscence of the episiorraphy suture; purulent effusion from episiorraphy; urinary tract infection; pelvic inflammatory disease or vulvovaginitis.

Notes

Blinding was not possible although an effort was made to keep the hypothesis unknown to staff and participants.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomisation was done in blocks of 2 (20%), 4 (60%) and 6 (20%) using Ralloc® allocation software.

Allocation concealment (selection bias)

Low risk

Opaque envelope with sequential numbering and instructions was opened.

Blinding (performance bias and detection bias)
All outcomes

High risk

Not done.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

There were 12 protocol violations; women who did not fulfil the inclusion criteria were identified and excluded from the final analysis (4 allocated to enema, 8 to no enema). The remaining women were analysed by intention‐to‐treat; losses to follow‐up were 35/217 (16%) in the enema group and 24/214 (11%) in the control group (P = 0.14). Losses to follow‐up among newborns were 18% in the enema group and 11% in the control group.

Selective reporting (reporting bias)

Unclear risk

Protocol of the study is not available.

Other bias

Low risk

Information was provided concerning baseline demographics. Declarations of interest are declared.

Methods

Randomised clinical trial, with stratified allocation (primigravid vs multigravid). Randomisation method was not explained.

Participants

Women entering labour ward during the first stage of labour, for vaginal delivery, single pregnancy and 37 or more weeks of gestation. Exclusion criteria included diabetes, cardiac disease or pregnancy complicated by antepartum haemorrhage or severe pre‐eclampsia. 370 women were eligible and 222 (60%) agreed to participate.

Interventions

Low‐volume disposable phosphate enema in the study group vs no enema. Inclusion bias could have occurred when the clinic staff avoided the inclusion of women who had faecal deposition prior to admission.

Outcomes

Faecal contamination was evaluated with an arbitrary scale, not validated, previously described by Romney and Gordon (Romney 1981).
Infection evaluation is not clear. Follow‐up time is not clearly discussed, but there are no data suggesting that women were followed up after leaving the hospital. Infections were confirmed bacteriologically and association between the organism and soiling was established by a microbiologist and a research sister.
Duration of labour: it was stratified between primigravidae and multigravidae. Data were collected in 6 ordinal and arbitrary categories. No clear time of follow‐up.

Notes

Stratification would be better done by parity instead of gravidity. Randomisation method was not discussed in the article.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not reported.

Allocation concealment (selection bias)

Unclear risk

Not reported.

Blinding (performance bias and detection bias)
All outcomes

High risk

Not done.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

There are some missing data in outcomes' results.

Selective reporting (reporting bias)

Unclear risk

Protocol of the study is not available. In the Drayton 1984 study the means to assess infection as well as the time of follow‐up was not reported by the authors. Infection rates were remarkably low in newborns and puerperal women as compared to the study from Colombia (Cuervo 2006).

Other bias

High risk

Inclusion bias seemed to happen when clinic staff excluded women if they had faecal soiling prior to their evaluation (time span unspecified). The authors provide no demographic data that would be relevant to know the external validity of the study.

Methods

Randomised clinical trial. Randomisation method not explained.

Participants

1027 pregnant women with labour pain were randomised to receive enema vs no enema.
Inclusion criteria: all were in the gestational age range of 37‐42 weeks and met the inclusion criteria consisting of living singleton pregnancy, vertex presentation, having normal bowel function, and with true labour.
Exclusion criteria: the pregnancies with medical or obstetric complications such as history of premature rupture of membranes, unexplained vaginal bleeding, previous uterine scar or previous antibiotics usage within 7 days before admission were excluded from the present study.

Interventions

Experiment group: the enema in the present study (Uni‐ma enema) consisted of sodium biphosphate and sodium phosphate 118 mL.
Control group: no enema.

Outcomes

Faecal contamination rate during the second stage of labour with an arbitrary scale; neonatal infection; duration of labour; route of delivery; degree of perineal tear; and satisfactory level of parturients and medical staff using the Likert scale. Women and babies were followed up for 4 days.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not reported.

Allocation concealment (selection bias)

Unclear risk

Not reported.

Blinding (performance bias and detection bias)
All outcomes

High risk

Not done.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

There are no missing data in outcomes' results.

Selective reporting (reporting bias)

Unclear risk

Protocol of the study is not available.

Other bias

Low risk

Information was provided concerning baseline demographics. Declarations of interest are not declared.