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Premature Rupture of Membranes at 34 to 37 Weeks' Gestation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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

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.

Condition or disease Intervention/treatment Phase
Premature Rupture of Membrane Procedure: induction of labor Procedure: follow up Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Arm Intervention/treatment
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 :
  1. 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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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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).
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Responsible Party: Asmaa Abd El Sattar Ahmed, Principal investigator, Assiut University Identifier: NCT03689062    
Other Study ID Numbers: PROM
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Fetal Membranes, Premature Rupture
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries