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Management of Women With PROM at TermNCT03435263

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

An observational study of Management of Women With PROM at Term, run by Ain Shams University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 20 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Management of Women With PROM at Term
What is being tested?
home management
How many people
72 participants
Where
1 siteEgypt
Study dates
1 Feb 2018to Apr 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

ahmed mahmoud hussein, MD contact

01205055563

ahmedmhmoud82@yahoo.com

Rehab Rehab Abdel-Lateef Khaled, M.B.B.Ch contact

01004105889

Egypt1 site, 1 recruiting
  • Ain Shams University

    Cairo

    ahmed mahmoud hussein, MD, 01205055563, ahmedmhmoud82@yahoo.com

    Rehab Abdel-Lateef Khaled, M.B.B.Ch, 01004105889

    Recruiting

Other trials in Egypt

About this study

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

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)

Being tested
home management
Keywords
premature rupture of membranes
Medical subject headings
Fetal Membranes, Premature Rupture

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • home managementOther

    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

Study groups in NCT03435263
Study groupRoleWhat they receive
hospital admission group BWomen presented with premature rupture of membranes will be admitted at hospital.
home management group Ahome management
Receives: Other: home management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. latency period.

    time form rupture of membranes till starting labor

    Measured: up to 24 hours

Secondary outcomes (1)
  1. NICU admission

    neonatal ICU admission

    Measured: first 24 hours after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2018
  2. Study start1 Feb 2018
  3. Primary completionFeb 2019 (estimated)
  4. Study completionApr 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03435263
Sponsor's protocol ID
ain shams university protocol
Status last verified
Feb 2018
First submitted
6 Feb 2018
Last updated
19 Feb 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Management of Women With PROM at Term, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact ahmed mahmoud hussein, MD (01205055563, ahmedmhmoud82@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

latency period. (time frame: up to 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.

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