Hospital Admission Versus Home Management in Women With Premature Rupture of Membranes :RCT

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03435263
Recruitment Status : Recruiting
First Posted : February 16, 2018
Last Update Posted : February 16, 2018
Information provided by (Responsible Party):
ahmed mahmoud hussein, Ain Shams University

Brief Summary:
According to high tendency for admission of cases of premature rupture of membranes (PROM) for fear of maternal & fetal complications, we compare here between cases managed at hospital with other managed at home for if there any difference between in maternal and neonatal outcome.

Condition or disease Intervention/treatment
Management of Women With PROM at Term Other: home management

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hospital Admission Versus Home Management in Women Premature Rupture of Membranes:RCT
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
hospital admission group B
Women presented with premature rupture of membranes will be admitted at hospital.
home management group A
home management
Other: home management
pregnant women presented with PROM will be randomized into 2 groups group a will be discharged home after initial assessment and group B will be admitted to hospital as usual

Primary Outcome Measures :
  1. latency period. [ Time Frame: up to 24 hours ]
    time form rupture of membranes till starting labor

Secondary Outcome Measures :
  1. NICU admission [ Time Frame: first 24 hours after delivery ]
    neonatal ICU admission

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant women at term pregnancy with PROM
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study will be carried out on 72 pregnant women recruited from Obstetric Department of Ain Shams University Maternity Hospital presented with PROM after 37 weeks of gestation

Inclusion Criteria:

- Maternal age 20-35 years old. Singleton pregnancy. Patient presented with PROM. Gestational age >37 weeks. Estimated fetal weight 2.5-4 kg . Cephalic presentation. No evidence of chorioamnionitis. Reassuring tests of fetal wellbeing: non stress tests (CTG). No signs of infection: fever or tachycardia . Clear AF. No contraction.

Exclusion Criteria:

Maternal age < 20 or > 35 years old. Multiple pregnancy. Rupture of membranes before 37 weeks of gestation or postdate. Suspected IUGR. SuspectedFetal weight > 4 kg (suspected by clinical examination or ultrasound).

Congenital fetal anomalies. Malpresentation or malposition. Placental abnormalities. High risk pregnancy as hypertension, DM and pre-eclampsia . Evidence suggesting onset of spontaneous delivery (e.g.: vaginal bleeding or uterine contractions).

Previous cesarean section or other uterine surgery. Presence of signs of chorioamnionitis. Presence of signs of fetal distress. Meconium stained liquor. Mental condition rendering

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03435263

Contact: ahmed mahmoud hussein, MD 01205055563
Contact: Rehab Rehab Abdel-Lateef Khaled, M.B.B.Ch 01004105889

Ain Shams University Recruiting
Cairo, Egypt
Contact: ahmed mahmoud hussein, MD    01205055563   
Contact: Rehab Abdel-Lateef Khaled, M.B.B.Ch    01004105889      
Sponsors and Collaborators
Ain Shams University
Principal Investigator: ahmed mahmoud hussein, MD Ain Shams University

Responsible Party: ahmed mahmoud hussein, lecturer of obstetrics and gyncology. MD, Ain Shams University Identifier: NCT03435263     History of Changes
Other Study ID Numbers: ain shams university protocol
First Posted: February 16, 2018    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ahmed mahmoud hussein, Ain Shams University:
premature rupture of membranes

Additional relevant MeSH terms:
Premature Birth
Fetal Membranes, Premature Rupture
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries