ClinicalTrials.gg
Status unknownNCT03435263Updated Feb 19, 2018

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

An observational study in Management of Women With PROM at Term, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-19.

Sponsored by Ain Shams University · Observational

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
72
Ages
20 Years to 35 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 12 studies in Fetal Membranes, Premature Rupture with a site in Egypt — 2 open to participants now, 2 under way, none of them phase 3. Fetal Membranes, Premature Rupture · Egypt.

Started
2018
with 5 others
Observational
8 of 12
2 open now
Registered
4th of 12
by date
Lead sponsor
3 of 12
Ain Shams University

Among the 12 studies in Fetal Membranes, Premature Rupture with a site in Egypt, this one is one of 6 that started in 2018, is one of 8 observational ones, and was the 4th registered.

Fetal Membranes, Premature Rupture

100 studies on the registry are indexed under Fetal Membranes, Premature Rupture; 23 are open to participants now.

Browse Fetal Membranes, Premature Rupture studies →

Open to participants now

2 of the 12 studies in Fetal Membranes, Premature Rupture with a site in Egypt are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 12 Fetal Membranes, Premature Rupture studies recruiting now, 7 (58%) set no upper age limit and 5 (42%) stop at 75 or younger; 3 take children under 18; 5 take healthy volunteers.

This study: 20 Years to 35 Years · female · healthy volunteers too.

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02

Study 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.

Read the detailed description

Premature rupture of membranes (PROM) refers to rupture of fetal membranes prior to onset of labor at term (> 37 weeks) (American college of obstetrician \& gynecologist, 2007; Caughey et al., 2008).

A premature rupture of membranes (PROM) is observed in 8% of all pregnancies after 37 wk of gestational age,3% before and 5% after 37 weeks of gestation (Popowski et al., 2011;Keith, 2005) These membranes form an adjustable container for a developing and moving fetus, but it has limited life time, existing only to the point of programmed rupture at term, which is a normal event during the first stage of labor (Goldenberg and Rouse, 1998). As fetal membranes act as a barrier to ascending infection, so once membranes rupture both mother \& fetus are at risk of infection and other complications (American college of obstetrician \& gynecologist , 2007).

The latent period of labor is the time from rupture of membranes to the onset of effective uterine contractions, as this period tends to increase the risk of maternal and fetal infection, maternal infection termed chorioamnionitis which occurs in 3-5% of cases of PROM. While fetal infection occurs in about 15-20% in those with chorioamnionitis. Fetal infection may occur as septicemia, pneumonia, UTI, local infection as omphalitis (infection of the umbilical cord or conjunctivitis (Benedetto et al.,2004).

Other complications that may associated with PROM include umbilical cord prolapse in about 1.5% of cases of PROM. Placental abruption, caesarean delivery, postpartum hemorrhage and postpartum infection (Modena et al.,2004).

Correct diagnosis of PROM has great importance because failure to diagnose can lead to unwanted obstetric complications as chorioamnionitis, preterm birth. On the other hand over diagnose can lead to unnecessary intervention like hospitalization. The approach to diagnose rupture of membrane is clinical , with over 90% of cases being confirmed bases on the presence of suspicious history or ultrasonographic finding followed be documentation of fluid passing from the cervix (Hasan and Cevder et al., 2007).

The causes of PROM is not clearly understood, but the following risk factors that have been shown to increase the chance of its happening. In many cases, however no risk factors can be idintified.

  1. Infection: UTI, STD, lower genital infection (ex: bacterial vaginosis).
  2. Intrauterine infection.
  3. Multiple previous pregnancies.
  4. Cervical incompetency.
  5. Hydramnios: too much AF.
  6. Nutritional deficits.
  7. Family history of PROM .(Ashley et al., 2003) . 8- Low socioeconomic status.

9-Multiple gestation: being pregnant with two or more fetuses at one time. 10- Previous preterm delivery. (Andrew et al.,2000) 11- Having had episodes of bleeding anytime during pregnancy. 12- Invasive procedure(ex: amniocentesis). 13- Being underweight. 14- Cigarette smoking during pregnancy(Jones., 2004) 15- Illicit drug use during pregnancy. 16- Having had PROM or preterm labor in previous pregnancy.(Parry., 2004) We observe in over 60% of the cases spontaneous labor begins within 24 hours, in 95% within 72 hours. often labor is induced after 24 hours because of the risk of maternal \& neonatal is rising.

Majority of clinicians advise hospital care to allow monitoring and detection of problems. But for low risk patients fulfilling strict criteria sometimes home management is possible.

The initial management of a woman presenting with suspecting PROM should focus on confirming the diagnosis, validating the gestational age as maternal and fetal risks vary with the gestational age at time of membranes rupture as proved by (Morales and Talley. ,1993 ) .

It is important to make a distinction between term PROM and preterm PROM (PPROM) which is rupture of membranes before term (\<37 weeks), as the conditions have different etiologies, risks and recommended management plans (Jones., 2004)

03

Conditions studied

  • Management of Women With PROM at Term

Keywords

  • premature rupture of membranes
04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
72 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • Otherhome 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

06

What researchers measure

Primary outcomes

  1. latency period.

    time form rupture of membranes till starting labor

    Time frame: up to 24 hours

Secondary outcomes

  1. NICU admission

    neonatal ICU admission

    Time frame: first 24 hours after delivery

07

Study locations

1 of 1 sites recruiting
  • Ain Shams University
    Cairo, Egypt
    Recruiting
    • ahmed mahmoud hussein, MD · Contactahmedmhmoud82@yahoo.com · 01205055563
    • Rehab Abdel-Lateef Khaled, M.B.B.Ch · Contact01004105889
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2018 (actual). Primary completion is estimated for Feb 2019, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 6, 2018
First posted
Feb 19, 2018
StartActual
Feb 1, 2018
Primary completionEst.
Feb 2019
CompletionEst.
Apr 2019
Last update
Feb 19, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03435263
Responsible party
ahmed mahmoud hussein (lecturer of obstetrics and gyncology. MD, Ain Shams University) — Principal investigator
First posted
Feb 19, 2018
Start date
Feb 1, 2018
Primary completion
Feb 2019 (estimated)
Completion
Apr 2019 (estimated)
Last update
Feb 19, 2018

Study contacts

ahmed mahmoud hussein, MD
Contact
ahmedmhmoud82@yahoo.com
01205055563
Rehab Rehab Abdel-Lateef Khaled, M.B.B.Ch
Contact
01004105889
ahmed mahmoud hussein, MD
principal investigator · Ain Shams University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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