Premature Rupture of Membranes at 34 to 37 Weeks' Gestation

Premature Rupture of Membrane Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03689062
• Other study ID #: PROM
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2019
• Est. completion date: March 2020

Study information

• Verified date: March 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: March 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Premature Birth
• Premature Rupture of Membrane
• Rupture

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the percentage of patients with chorioamnionitis	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	24 hours