Premature Rupture of Membranes at 34 to 37 Weeks' Gestation

Assiut University

Status: Unknown

Conditions: Premature Rupture of Membrane

Treatments: Procedure: follow up; Procedure: induction of labor

Study type: Interventional

Funder types: Other

Identifiers

NCT03689062

PROM

Details and patient eligibility

About

Prelabour rupture of membrane is defined as rupture of membranes prior to the onset of labour. Approximately 8% of pregnant women at term experience PROM, but the decision as to how term PROM should be managed clinically remains controversial, and there is wide variation in practice with no clear consensus on what constitutes optimal treatment. Although for the majority of women labour will start spontaneously within 24 hours following term PROM, up to 4%of women will not experience spontaneous onset of labour within seven days.

Enrollment: 120 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Preterm premature rupture of membranes.
• Singleton gestation.
• Pregnant between 34 weeks 0 days to 36 weeks 6 days.

Exclusion criteria

• Non cephalic presentation.
• fetal distress.
• Labour on admission.
• Medical or obstetric complications such as(suspected chorioamnionitis ,hypertensive disorders, diabetes mellitus , active genital herpes , placenta previa , infection, meconium stained amniotic fluid ,severe fetal anomalies).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

conservative group

Active Comparator group

Description:

patient assigned to the observation group will be assessed in the labor and delivery suite for 2 to 4 hours with continuous external fetal heart rate monitoring and tocodynamometry. In the absence of non reassuring fetal status , initiation of labor , or infection , these women will be transferred to antepartum room where maternal vital signs. Patients will be restricted to bed rest with bathroom privileges and remained hospitalized until delivary .

Treatment:

Procedure: follow up

active group

Experimental group

Description:

Patients assigned to active management will receive induction of labour with intravenous oxytocin with use of controlled infusion pump Oxytocin will be administered by continuous intravenous infusion beginning at 0.5 mU/min , doubling the dose every 30 minutes to 2mU/min , and then increasing by 2 mU/min every 30 minutes there after until a satisfactory labor pattern is achieved.

Treatment:

Procedure: induction of labor