Premature Rupture of Membranes at 34 to 37 Weeks' Gestation

NCT ID: NCT03689062

Last Updated: 2019-03-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-31
• Study Completion Date: 2020-03-31

Brief Summary

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.

Conditions

Premature Rupture of Membrane

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

conservative group

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 .

Group Type: ACTIVE_COMPARATOR

follow up

Intervention Type: PROCEDURE

hospitalization and antibiotics

active group

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.

Group Type: EXPERIMENTAL

induction of labor

Intervention Type: PROCEDURE

oxytocin intravenous drip

Interventions

induction of labor

oxytocin intravenous drip

Intervention Type: PROCEDURE

follow up

hospitalization and antibiotics

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Asmaa Abd El Sattar Ahmed

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PROM

Identifier Type: -

Identifier Source: org_study_id