Premature Rupture of MembraneNCT03689062
Premature Rupture of Membranes at 34 to 37 Weeks' Gestation
A study testing induction of labor and follow up in people with Premature Rupture of Membrane, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Premature Rupture of Membrane
- What is being tested?
- induction of labor and follow up
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- May 2019to Mar 2020
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Preterm premature rupture of membranes.
- Singleton gestation.
- Pregnant between 34 weeks 0 days to 36 weeks 6 days.
Who cannot join
- 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).
About this study
Official title: Premature Rupture of Membranes at 34 to 37 Weeks' Gestation :Active vs Conservative Management
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
- Being tested
- induction of labor, follow up
- 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.
induction of laborProcedure or surgery
oxytocin intravenous drip
follow upProcedure or surgery
hospitalization and antibiotics
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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. Receives: Procedure: induction of labor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study startMay 2019 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Rupture of MembraneStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Abd El Sattar Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689062
- Sponsor's protocol ID
- PROM
- Status last verified
- Mar 2019
- First submitted
- 27 Sep 2018
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premature Rupture of Membranes at 34 to 37 Weeks' Gestation :Active vs Conservative Management
- ClinicalTrials.gov ID
- NCT03689062
- Acronym / sponsor ID
- PROM
- Conditions
- Premature Rupture of Membrane
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2019 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conservative group | Active comparator | Procedure: follow uppatient 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 . |
| active group | Experimental | Procedure: induction of laborPatients 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Preterm premature rupture of membranes.
- Singleton gestation.
- Pregnant between 34 weeks 0 days to 36 weeks 6 days.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| induction of laboroxytocin intravenous drip | Procedure or surgery | active group |
| follow uphospitalization and antibiotics | Procedure or surgery | conservative group |
Primary outcome
the percentage of patients with chorioamnionitis
Time frame: 24 hours
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing induction of labor and follow up in people with Premature Rupture of Membrane, run by Assiut University.
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 3 inclusion and 4 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 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage of patients with chorioamnionitis (time frame: 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 25 Mar 2019.