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Clinical Trials/NCT03689062
NCT03689062
Unknown
Not Applicable

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

Assiut University0 sites120 target enrollmentMay 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Premature Rupture of Membrane
Sponsor
Assiut University
Enrollment
120
Primary Endpoint
the percentage of patients with chorioamnionitis
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2019
End Date
March 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Asmaa Abd El Sattar Ahmed

Principal investigator

Assiut University

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).

Outcomes

Primary Outcomes

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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