Prelabor Rupture of MembranesNCT04143685
Labor Induction With Misoprostol Versus Oxytocin in Women With Premature Rupture of Membranes
A study testing Misoprostol and Oxytocin in people with Prelabor Rupture of Membranes and Premature Rupture of Membrane, run by sammour.rami at 1 site in Israel.
Trial summary
This study compares the rate of vaginal delivery after induction of labor with misoprostol versus oxytocin in women with prelabor rupture of membranes. Participants will be randomized to receive either oral misoprotsol every four hours until going into labor, or intravenous oxytocin in increasing dose. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prelabor Rupture of Membranes, Premature Rupture of Membrane
- What is being tested?
- Misoprostol and Oxytocin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Dec 2019to 1 Oct 2021
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women in their 1st - 4th delivery
- Term prelabor rupture of membranes (37+0 to 42+0 gestational age)
- Vertex presentation
- Singleton pregnancy
Who cannot join
- Multiple pregnancy
- Previous cesarean section
- Chorioamnionitis on admission
- >2 symptomatic uterine contractions in 10 minutes
- Prostaglandins hypersensitivity
- Contraindication for vaginal delivery
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Bnai Zion Medical Center
Haifa
Rami Sammour, MD, +97248359052, rsammour2002@gmail.com
About this study
This study compares the rate of vaginal delivery after induction of labor with misoprostol versus oxytocin in women with prelabor rupture of membranes. Participants will be randomized to receive either oral misoprotsol every four hours until going into labor, or intravenous oxytocin in increasing dose.
Read the detailed description
Misoprostol is a synthetic prostaglandin analogue commonly used for labor induction. It causes uterine contractions and ripening of the cervix. Oxytocin sold under the brand name Pitocin among others, is a medication made from the peptide oxytocin and is used to cause contraction of the uterus to start labor.
This randomized controlled trial will compare induction of labor in women with term premature rupture of the membranes and unripe cervix using misoprostol versus oxytocin. The primary outcome is the rate of vaginal delivery. Secondary outcomes will include cesarean section rate, time interval from induction of labor to delivery, neonatal morbidity, patient satisfaction and side effects, as well as chorioamnionitis.
- Being tested
- Misoprostol, Oxytocin
- Keywords
- PROM
- 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.
MisoprostolDrug
Also called Cytotec, PGE1
Oral administration of cytotec every 4 hours until a maximum of 6 doses
OxytocinDrug
Also called Pitocin
Intravenous infusion of Pitocin through an IVAC until delivery
| Study group | Role | What they receive |
|---|---|---|
| misoprostol | Active comparator | misoprostol 50 mcg tablet by mouth every four hours for maximum dosage of six Receives: Drug: Misoprostol |
| oxytocin | Active comparator | Oxytocin 10 IU in 1000 mL Standard solution. Starting with 10 mL/hr infusion rate and increasing by 10mL/hr every 20 minutes until achieving 3-5 regular uterine contractions every 10 minutes (as recorded by cardiotocography) Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal delivery rate
Measured: During delivery
Secondary outcomes (7)
Operative delivery rate, Cesarean section rate, time interval from induction of labor to delivery
Measured: During delivery
chorioamnionitis rate
intra-amniotic infection during or after delivery representing in possible combination of maternal fever, fetal tachycardia, maternal leukocytosis, Histopathologic evidence of infection or inflammation or both in the placenta, fetal membranes, or the umbilical cord vessels
Measured: During or after delivery up to 7 days
Uterine tachysystole
Measured: During delivery
Neonatal morbidity
Apgar score, , ,
Measured: After delivery until discharge
Neonatal morbidity
Umbilical Cord Blood Gases
Measured: immediately after delivery
Neonatal morbidity
NICU admission
Measured: up to 7 days after delivery
Neonatal morbidity
Antibiotic administration
Measured: up to 7 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start1 Dec 2019
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prelabor Rupture of MembranesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- sammour.rami
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, sammour.rami, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143685
- Sponsor's protocol ID
- MISOX-001
- Status last verified
- Oct 2019
- First submitted
- 19 Dec 2018
- Last updated
- 29 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Labor Induction With Misoprostol Versus Oxytocin in Women With Premature Rupture of Membranes
- ClinicalTrials.gov ID
- NCT04143685
- Acronym / sponsor ID
- MISOX-001
- Keywords
- PROM
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- sammour.ramiOther government
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 29 Oct 2019 (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.
This study compares the rate of vaginal delivery after induction of labor with misoprostol versus oxytocin in women with prelabor rupture of membranes. Participants will be randomized to receive either oral misoprotsol every four hours until going into labor, or intravenous oxytocin in increasing dose.
Detailed description
Misoprostol is a synthetic prostaglandin analogue commonly used for labor induction. It causes uterine contractions and ripening of the cervix. Oxytocin sold under the brand name Pitocin among others, is a medication made from the peptide oxytocin and is used to cause contraction of the uterus to start labor.
This randomized controlled trial will compare induction of labor in women with term premature rupture of the membranes and unripe cervix using misoprostol versus oxytocin. The primary outcome is the rate of vaginal delivery. Secondary outcomes will include cesarean section rate, time interval from induction of labor to delivery, neonatal morbidity, patient satisfaction and side effects, as well as chorioamnionitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| misoprostol | Active comparator | Drug: Misoprostolmisoprostol 50 mcg tablet by mouth every four hours for maximum dosage of six |
| oxytocin | Active comparator | Drug: OxytocinOxytocin 10 IU in 1000 mL Standard solution. Starting with 10 mL/hr infusion rate and increasing by 10mL/hr every 20 minutes until achieving 3-5 regular uterine contractions every 10 minutes (as recorded by cardiotocography) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women in their 1st - 4th delivery
- Term prelabor rupture of membranes (37+0 to 42+0 gestational age)
- Vertex presentation
- Singleton pregnancy
Key exclusion criteria (6 listed)
- Multiple pregnancy
- Previous cesarean section
- Chorioamnionitis on admission
- >2 symptomatic uterine contractions in 10 minutes
- Prostaglandins hypersensitivity
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 |
|---|---|---|
| MisoprostolAlso: Cytotec, PGE1Oral administration of cytotec every 4 hours until a maximum of 6 doses | Drug | misoprostol |
| OxytocinAlso: PitocinIntravenous infusion of Pitocin through an IVAC until delivery | Drug | oxytocin |
Primary outcome
Vaginal delivery rate
Time frame: During delivery
7 secondary outcomes
Operative delivery rate, Cesarean section rate, time interval from induction of labor to delivery
Time frame: During delivery
chorioamnionitis rate
Time frame: During or after delivery up to 7 days
Uterine tachysystole
Time frame: During delivery
Neonatal morbidity
Time frame: After delivery until discharge
Neonatal morbidity
Time frame: immediately after delivery
Neonatal morbidity
Time frame: up to 7 days after delivery
Neonatal morbidity
Time frame: up to 7 days after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol and Oxytocin in people with Prelabor Rupture of Membranes and Premature Rupture of Membrane, run by sammour.rami at 1 site in Israel.
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 4 inclusion and 6 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 29 Jan 2020. 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 Israel. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal delivery rate (time frame: During delivery). 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 29 Jan 2020.