search
Back to results

Premature Rupture of Membranes at 34 to 37 Weeks' Gestation

Primary Purpose

Premature Rupture of Membrane

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
induction of labor
follow up
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Premature Rupture of Membrane

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    conservative group

    active group

    Arm Description

    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 .

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    September 27, 2018
    Last Updated
    March 22, 2019
    Sponsor
    Assiut University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03689062
    Brief Title
    Premature Rupture of Membranes at 34 to 37 Weeks' Gestation
    Official Title
    Premature Rupture of Membranes at 34 to 37 Weeks' Gestation :Active vs Conservative Management
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2019 (Anticipated)
    Primary Completion Date
    November 2019 (Anticipated)
    Study Completion Date
    March 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premature Rupture of Membrane

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    conservative group
    Arm Type
    Active Comparator
    Arm Description
    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 .
    Arm Title
    active group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    induction of labor
    Intervention Description
    oxytocin intravenous drip
    Intervention Type
    Procedure
    Intervention Name(s)
    follow up
    Intervention Description
    hospitalization and antibiotics
    Primary Outcome Measure Information:
    Title
    the percentage of patients with chorioamnionitis
    Description
    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
    Time Frame
    24 hours

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    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).

    12. IPD Sharing Statement

    Learn more about this trial

    Premature Rupture of Membranes at 34 to 37 Weeks' Gestation

    We'll reach out to this number within 24 hrs