Premature Rupture of Membranes at 34 to 37 Weeks' Gestation
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|ClinicalTrials.gov Identifier: NCT03689062|
Recruitment Status : Unknown
Verified March 2019 by Asmaa Abd El Sattar Ahmed, Assiut University.
Recruitment status was: Not yet recruiting
First Posted : September 28, 2018
Last Update Posted : March 25, 2019
Information provided by (Responsible Party):
Asmaa Abd El Sattar Ahmed, Assiut University
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.
|Condition or disease||Intervention/treatment||Phase|
|Premature Rupture of Membrane||Procedure: induction of labor Procedure: follow up||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Premature Rupture of Membranes at 34 to 37 Weeks' Gestation :Active vs Conservative Management|
|Estimated Study Start Date :||May 2019|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||March 2020|
Active Comparator: 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 .
Procedure: follow up
hospitalization and antibiotics
Experimental: 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.
Procedure: induction of labor
oxytocin intravenous drip
Primary Outcome Measures :
- the percentage of patients with chorioamnionitis [ Time Frame: 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
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