Fetal InfectionNCT04307069
Management of Prelabor Rupture of the Membranes at Term
A study testing Oxytocin in people with Fetal Infection and Chorioamnionitis, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Prolonged rupture of membranes has been associated with increased risk of chorioamnionitis and endometritis. In this study the investigators will investigate whether an early intervention to augment labor with oxytocin is superior to expected management for spontaneous delivery (up to 24 hours). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Fetal Infection, Chorioamnionitis, Endometritis
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 524 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2020to 1 May 2024
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Primiparous women with a singleton pregnancy that are admitted with prelabor rupture of membranes.
- Women at gestational age 370/7 or more.
- Vertex presentation.
Who cannot join
- Age 18 and under.
- High order gestation.
- Women with contraindication for a vaginal delivery.
- Active labor.
- Documented fetal anomalies.
- Known or suspected intrauterine infection (temperature > 38 degrees, leucocytosis).
- Non reassuring fetal heart rate tracing.
- Positive group B streptococcus status.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam
Ramat Yishai, 3009500
Gal Bachar, 0524858699
About this study
Official title: Comparison Between Two Protocols for Management of Prelabor Rupture of the Membranes at Term
Prolonged rupture of membranes has been associated with increased risk of chorioamnionitis and endometritis. In this study the investigators will investigate whether an early intervention to augment labor with oxytocin is superior to expected management for spontaneous delivery (up to 24 hours).
Read the detailed description
Prelabor rupture of the membranes (PROM) refers to rupture of the fetal membranes prior to the onset of regular uterine contractions.
PROM at term can be managed actively by induction of labor or expectantly by waiting for the onset of a spontaneous labor. Several studies have shown an association between expectant management and higher rates of maternal and neonatal adverse outcomes, especially infections. Furthermore, expectant management has been shown to increase the risk for cesarean deliveries (CD), chronic lung disease, cerebral palsy and neonatal mortality. It is suggested that the risk for those complications increase proportionally with the longer the duration of ruptured membranes. Others disagree with those associations.
In this study the investigators will investigate whether early administration of oxytocin is superior to expectant management of 24 hours in patients with PROM at term, in terms of time to delivery and maternal and neonatal adverse outcomes, regardless of bishop score.
- Being tested
- Oxytocin
- Medical subject headings
- Chorioamnionitis, Endometritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called pitocin
The drug wil be adminisrate for augmentation of labor at admission.
| Study group | Role | What they receive |
|---|---|---|
| Immediate oxytocin infusion | Experimental | Once the patient will arrive at the maternity ward with prelabor rupture of membranes, she will receive oxytocin for augmentation of labor. Receives: Drug: Oxytocin |
| Expectant management for 24 hours | Experimental | Once the patient will arrive at the maternity ward with prelabor rupture of membranes, we will wait for spontaneous delivery to occur. After 24 hours of rupture of membranes, the woman will receive oxytocin for augmentation of labor. Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal infectious morbidity
Maternal chorioamnionitis and/ or endometritis
Measured: Up to 48 hours postpartum
Secondary outcomes (3)
Length of latent and active phases of labor.
According to vaginal examinations during labor
Measured: During Labor
Adverse maternal outcome
infectious (chorioamnionitis/endometritis), serious maternal morbidity and mortality (death, cardiac arrest, respiratory arrest, ICU admission), post-partum hemorrhage (PPH), obstetric anal sphincter injuries (OASIS).
Measured: Up to 48 hours postpartum
Adverse neonatal outcome
stillbirth, infectious disease (sepsis, meningitis, pneumonia), 5-minute Apgar score < 7, umbilical artery pH < 7.0, NICU admission, RDS, use of mechanical ventilation, NEC.
Measured: Up to 48 hours postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start1 May 2020
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal InfectionStudies 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
- 524 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gal Bachar, MD, Principal investigator, Rambam Medical Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307069
- Sponsor's protocol ID
- Rambam Health-Care Center
- Status last verified
- Apr 2024
- First submitted
- 11 Mar 2020
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- 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 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Protocols for Management of Prelabor Rupture of the Membranes at Term
- ClinicalTrials.gov ID
- NCT04307069
- Acronym / sponsor ID
- Rambam Health-Care Center
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 524 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 13 Mar 2020 (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.
Prolonged rupture of membranes has been associated with increased risk of chorioamnionitis and endometritis. In this study the investigators will investigate whether an early intervention to augment labor with oxytocin is superior to expected management for spontaneous delivery (up to 24 hours).
Detailed description
Prelabor rupture of the membranes (PROM) refers to rupture of the fetal membranes prior to the onset of regular uterine contractions.
PROM at term can be managed actively by induction of labor or expectantly by waiting for the onset of a spontaneous labor. Several studies have shown an association between expectant management and higher rates of maternal and neonatal adverse outcomes, especially infections. Furthermore, expectant management has been shown to increase the risk for cesarean deliveries (CD), chronic lung disease, cerebral palsy and neonatal mortality. It is suggested that the risk for those complications increase proportionally with the longer the duration of ruptured membranes. Others disagree with those associations.
In this study the investigators will investigate whether early administration of oxytocin is superior to expectant management of 24 hours in patients with PROM at term, in terms of time to delivery and maternal and neonatal adverse outcomes, regardless of bishop score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate oxytocin infusion | Experimental | Drug: OxytocinOnce the patient will arrive at the maternity ward with prelabor rupture of membranes, she will receive oxytocin for augmentation of labor. |
| Expectant management for 24 hours | Experimental | Drug: OxytocinOnce the patient will arrive at the maternity ward with prelabor rupture of membranes, we will wait for spontaneous delivery to occur. After 24 hours of rupture of membranes, the woman will receive oxytocin for augmentation of labor. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Primiparous women with a singleton pregnancy that are admitted with prelabor rupture of membranes.
- Women at gestational age 370/7 or more.
- Vertex presentation.
Key exclusion criteria (8 listed)
- Age 18 and under.
- High order gestation.
- Women with contraindication for a vaginal delivery.
- Active labor.
- Documented 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 |
|---|---|---|
| OxytocinAlso: pitocinThe drug wil be adminisrate for augmentation of labor at admission. | Drug | Expectant management for 24 hours, Immediate oxytocin infusion |
Primary outcome
Maternal infectious morbidity
Time frame: Up to 48 hours postpartum
Maternal chorioamnionitis and/ or endometritis
3 secondary outcomes
Length of latent and active phases of labor.
Time frame: During Labor
Adverse maternal outcome
Time frame: Up to 48 hours postpartum
Adverse neonatal outcome
Time frame: Up to 48 hours postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- 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.
Gal Bachar, MD principal investigator
Rambam Medical Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin in people with Fetal Infection and Chorioamnionitis, run by Rambam Health Care Campus 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 3 inclusion and 8 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 12 Apr 2024. 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?
Contact Gal Bachar, MD (+972524858699, gal.bachar13@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal infectious morbidity (time frame: Up to 48 hours postpartum). 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 12 Apr 2024.