Premature Rupture of Membranes at 34 to 37 Weeks' Gestation

NCT03689062 — Not applicable, Unknown, 120 participants, Assiut University

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Premature Rupture of Membranes at 34 to 37 Weeks' Gestation :Active vs Conservative Management

Registry	NCT03689062
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	120 (Estimated)
Sponsor	Assiut University (Other)
Conditions	Premature Rupture of Membrane
Interventions	induction of labor, follow up (Procedure)
Dates	start 2019-05-01 (estimated), primary completion 2019-11-01 (estimated), completion 2020-03-01 (estimated), first posted 2018-09-28, last updated 2019-03-25

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
conservative group	Active comparator	Procedure: follow up	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 .
active group	Experimental	Procedure: induction of labor	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.

induction of labor (Procedure): oxytocin intravenous drip
follow up (Procedure): hospitalization and antibiotics

+Outcome measures

Primary outcomes

the percentage of patients with chorioamnionitis [24 hours]: Clinical chorioamnionitis is defined in the absence of other causes of hyperpyrexia by a temprature of >38 C with either uterine tenderness , leucocytosis , maternal or fetal tachycardia , or foul smelling vaginal discharge

+Eligibility

Sex: Female

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).