Premature Rupture of Membranes at 34 to 37 Weeks' Gestation

NCT03689062 | Unknown

• 1 other identifier: PROM
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Premature Rupture of Membrane

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

conservative group

ACTIVE COMPARATOR

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

active group

EXPERIMENTAL

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

Interventions

induction of labor PROCEDURE

oxytocin intravenous drip

active group

follow up PROCEDURE

hospitalization and antibiotics

conservative group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Preterm premature rupture of membranes.
• Singleton gestation.
• Pregnant between 34 weeks 0 days to 36 weeks 6 days.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Interventions

Labor, Induced

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: September 28, 2018
• Study Start: May 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: March 1, 2020
• Last Updated: March 25, 2019

Record last verified: 2019-03