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Updated: Oct 26, 2026
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Published on: December 31, 2015
Tocolytic therapy for preterm premature rupture of membranes: a systematic review and meta-analysis
Luisa Melo Lucas1, Ana Clara Felix de Farias Santos2, Pedro Henrique Costa Matos da Silva3
1Centro Universitário Alfredo Nasser Aparecida de GoiâniaGO Brazil Centro Universitário Alfredo Nasser, Aparecida de Goiânia, GO, Brazil.
Objective:
To evaluate the effects of tocolytic therapy on maternal and neonatal outcomes in women with preterm prelabor rupture of membranes (PPROM) compared with no tocolysis, based on evidence from randomized controlled trials.
Data Sources:
A systematic search was performed in MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) from database inception to July 2024. The search strategy included controlled vocabulary terms and free-text terms related to PPROM and tocolysis.
Study Selection:
Randomized controlled trials involving women with PPROM that compared any tocolytic therapy with no tocolysis or standard care were eligible for inclusion. Studies were selected independently by three reviewers, and disagreements were resolved by consensus.
Data Extraction And Synthesis:
Two reviewers independently extracted data using a standardized form. Risk of bias was assessed using the Cochrane Risk of Bias 2 tool. Dichotomous outcomes were summarized as odds ratios (ORs) with 95% confidence intervals (CIs) using a random-effects model. Heterogeneity was assessed using the I2 statistic. Analyses were performed using Review Manager (RevMan) version 5.4. The outcomes assessed included neonatal mortality, neonatal intensive care unit admission, necrotizing enterocolitis, intraventricular hemorrhage, and neonatal sepsis.
Results:
Four comparative studies, involving 372 participants including two randomized controlled trials and two non-randomized studies. Compared with no tocolysis or standard care, tocolytic therapy was not associated with a significant reduction in neonatal mortality (OR: 2.02; 95% CI: 0.51-8.01), neonatal intensive care unit admission (OR: 0.49; 95% CI: 0.02-14.57), necrotizing enterocolitis (OR: 1.35; 95% CI: 0.38-4.72), intraventricular hemorrhage (OR: 0.96; 95% CI: 0.01-138.63), or sepsis (OR: 1.18; 95% CI: 0.25-5.54).
Conclusion:
In women with PPROM, current evidence from randomized controlled trials does not demonstrate a clear neonatal benefit associated with tocolytic therapy compared with no tocolysis or standard care. Given the low certainty of evidence and the limited number of available studies, the routine use of tocolysis in this population remains uncertain and should be individualized until further high-quality randomized trials are available.Prospero registry: #CRD420251043906.