Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jun 4, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a treatment approach called tocolysis for women who have experienced a condition known as preterm premature rupture of membranes (PPROM) before 34 weeks of pregnancy. PPROM occurs when the amniotic sac breaks early, which can lead to complications for both the mother and baby. The goal of the study is to see if using tocolysis for a short period (48 hours) can help reduce health issues for the baby and mother in these cases.

To be eligible for the trial, participants must be women aged 18 or older, speak French, and be experiencing PPROM between 22 and 33 weeks of pregnancy. The baby must be alive and healthy at the time of enrollment. However, there are certain conditions that would prevent someone from joining, such as having PPROM for more than 24 hours before diagnosis or specific serious health issues. Participants who join the study will receive either the tocolytic treatment or a placebo (a substance with no active effect) for a short time, and their health outcomes will be monitored closely. This trial is actively recruiting participants, and it aims to provide valuable information about managing this challenging situation in pregnancy.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Preterm premature rupture of membranes (PPROM) between 220/7 - 336/7 weeks of gestation, as diagnosed by obstetric team
• • Singleton gestation
• • Fetus alive at the time of randomization (reassuring fetal heart monitoring)
• • 18 years of age or older
• • French speaking
• • Affiliated to social security regime or an equivalent system
• • Informed consent and signed
• Exclusion Criteria:
• • PPROM ≥ 24 hours before diagnosis
• • Ongoing tocolytic treatment at the time of PPROM
• • Tocolytic treatment with Nifedipine between PPROM diagnosis and randomization
• • Fetal condition contraindicating expectant management including chorioamnionitis, placental abruption, intrauterine fetal demise, non-reassuring fetal heart rate at the time of randomization
• • Cervical dilation \> 5 cm
• • Iatrogenic rupture caused by amniocentesis or trophoblast biopsy
• • Major fetal anomaly
• * Maternal allergy or contra-indication to Nifedipine or placebo drug components\*:
• • Myocardial infarction
• • Unstable angina pectoris
• • Hepatic insufficiency
• • Cardiovascular shock
• • Beta blockers
• • placebo drug components: lactose monohydrate, colloidal silica, microcrystalline cellulose
• • Coadministration of diltiazem or rifampicin
• • Hypotension (systolic pressure \< 90 mmHg)
• • Participation to another interventional research (category 1) in which intervention could interfere with TOCOPROM's results (efficacy and safety)