Premature Rupture of MembraneEarly Phase 1PROMMONCT04478942
PROMMO Trial: Oral Misoprostol vs IV Oxytocin
A Early Phase 1 study testing Misoprostol Oral Product and Intravenous Oxytocin in people with Premature Rupture of Membrane and Induction of Labor Affected Fetus / Newborn, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This is a prospective, randomized trial looking at the ideal method of labor induction for women with prelabor rupture of membranes and an unfavorable cervical Bishop score. The study will compare oral misoprostol and intravenous oxytocin. 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
- Premature Rupture of Membrane, Induction of Labor Affected Fetus / Newborn
- What is being tested?
- Misoprostol Oral Product and Intravenous 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
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2020to 14 Jan 2025
- Phase
- Early Phase 1
- 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
- Early Term to late term pregnancy (>37 weeks and 0 days and <42 weeks and 0 days)
- Late Preterm Pregnancy (34 weeks and 0 days and <37 weeks)
- Confirmed rupture of membranes by either sterile speculum exam or AmniSure
- Simplified Bishop Score ≤ 6
- Maternal Age > 18 years old
- Singleton gestation
- Appropriate gestational age dating by certain LMP or ultrasound performed prior to 20 weeks gestational age
Who cannot join
- Concern for intra-amniotic infection
- Previous Cesarean delivery
- Lack of appropriate dating criteria for the pregnancy
- Inability to give informed consent in the patient's native language
- Known bleeding disorder such as von Willebrand's disease or hemophilia
- Anticoagulation administration within 24 hours of delivery
Trial locations and contacts
1 site in 1 country.
United States1 site
UnityPoint Health- Meriter Hospital
Madison, Wisconsin, 53705-2216
About this study
Official title: PROMMO Trial: Prelabor Rupture of Membranes Managed With Oral Misoprostol Versus Intravenous Oxytocin
This is a prospective, randomized trial looking at the ideal method of labor induction for women with prelabor rupture of membranes and an unfavorable cervical Bishop score. The study will compare oral misoprostol and intravenous oxytocin.
Read the detailed description
The purpose of this study is to look at optimal induction management of prelabor rupture of membranes (PROM) at or beyond 34 weeks gestational age.
Objective 1: To determine if there is a decrease in time from initiation of induction of labor to vaginal delivery in women with an unfavorable cervix with the use of oral misoprostol versus intravenous oxytocin.
Hypothesis: Cervical ripening with misoprostol will be beneficial in women with an unfavorable cervix.
Sub objective 1: To determine if the use of oral misoprostol for cervical ripening decreases the rate of postpartum hemorrhage in women with PROM.
Hypothesis: Misoprostol use will result in significantly lower rate of postpartum hemorrhage.
Sub objective 2: To evaluate the rates of infectious morbidity in peripartum women and neonates exposed to misoprostol versus oxytocin in PROM.
Hypothesis: The use of oral misoprostol will result in lower rates of infectious morbidity in mother and neonate.
Sub objective 3: To analyze patient satisfaction surveys. Hypothesis: Patients in the oral misoprostol group will be more satisfied with their labor experience.
Exploratory Outcome To determine if there is a difference in cost between induction of labor in women with an unfavorable cervix with the use of oral misoprostol versus intravenous oxytocin.
Hypothesis: The use of oral misoprostol will be cost effective in women presenting with PROM and an unfavorable cervix.
- Being tested
- Misoprostol Oral Product, Intravenous Oxytocin
- 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.
Misoprostol Oral ProductDrug
Also called Oral Product
Misoprostol will be dosed using the preexisting UnityPoint Health-Meriter Protocol for oral misoprostol administration.
Intravenous OxytocinDrug
Also called IV Product
Intravenous oxytocin administration will also follow standard, UnityPoint Health-Meriter Protocol.
| Study group | Role | What they receive |
|---|---|---|
| oral misoprostol | Active comparator | At time of delivery, participants randomly assigned to either oral misoprostol will receive 50 mcg of Misoprostol every 4 hours up to 6 doses, OR until simplified Bishop score >6 (whichever is achieved first). Receives: Drug: Misoprostol Oral Product |
| intravenous oxytocin | Active comparator | At time of delivery, participants randomly assigned to intravenous oxytocin, will be administered the drug per standard of labor and delivery titrations. Receives: Drug: Intravenous Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint: Time from initial medication administration to vaginal delivery
time from initiation of induction of labor to vaginal delivery in women with an unfavorable cervix with the use of oral misoprostol versus intravenous oxytocin
Measured: Up to 72 hours
Secondary outcomes (5)
Secondary endpoint 1: Rate of Postpartum Hemorrhage
the rate of postpartum hemorrhage in women with prelabor rupture of membranes with use of oral misoprostol for cervical ripening
Measured: up to 24 hours for immediate postpartum hemorrhage
Secondary endpoint 2: Rate of Suspected or Confirmed Intrapartum Intramniotic Infection
Rates of infectious morbidity in peripartum women and neonates exposed to misoprostol versus oxytocin in prelabor rupture of membranes.
Measured: Prior to delivery
Secondary endpoint 3: Rate of Suspected Endometritis
patient satisfaction surveys
Measured: From delivery to 6 weeks postpartum
Secondary endpoint 4: Rate of Infectious Morbidity for Neonates
Neonatal infection that is diagnosed within the first 6 weeks of life related to maternal infection diagnosed by positive blood cultures or fever.
Measured: up to 6 weeks of life
Secondary endpoint 5: Participant Satisfaction as Measured by modified Labour Agentry Scale
The modified labour agentry scale has scores that indicate satisfaction with the patient's experience in labor
Measured: Postpartum day one with repeat instrument at 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start26 Oct 2020
- Primary completion14 Jan 2025
- Study completion14 Jan 2025
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 University of Wisconsin, MadisonThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacquelyn Adams, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478942
- Sponsor's protocol ID
- 2025-0770
- Other IDs
- A532860, SMPH/OBSTET & GYNECOL, Protocol Version 9/20/2023, 2020-0240
- Acronym
- PROMMO
- Status last verified
- Feb 2025
- First submitted
- 15 Jul 2020
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROMMO Trial: Prelabor Rupture of Membranes Managed With Oral Misoprostol Versus Intravenous Oxytocin
- ClinicalTrials.gov ID
- NCT04478942
- Acronym / sponsor ID
- PROMMO / 2025-0770
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 14 Jan 2025 (actual)
- Study completion
- 14 Jan 2025 (actual)
- First posted
- 21 Jul 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.
This is a prospective, randomized trial looking at the ideal method of labor induction for women with prelabor rupture of membranes and an unfavorable cervical Bishop score. The study will compare oral misoprostol and intravenous oxytocin.
Detailed description
The purpose of this study is to look at optimal induction management of prelabor rupture of membranes (PROM) at or beyond 34 weeks gestational age.
Objective 1: To determine if there is a decrease in time from initiation of induction of labor to vaginal delivery in women with an unfavorable cervix with the use of oral misoprostol versus intravenous oxytocin.
Hypothesis: Cervical ripening with misoprostol will be beneficial in women with an unfavorable cervix.
Sub objective 1: To determine if the use of oral misoprostol for cervical ripening decreases the rate of postpartum hemorrhage in women with PROM.
Hypothesis: Misoprostol use will result in significantly lower rate of postpartum hemorrhage.
Sub objective 2: To evaluate the rates of infectious morbidity in peripartum women and neonates exposed to misoprostol versus oxytocin in PROM.
Hypothesis: The use of oral misoprostol will result in lower rates of infectious morbidity in mother and neonate.
Sub objective 3: To analyze patient satisfaction surveys. Hypothesis: Patients in the oral misoprostol group will be more satisfied with their labor experience.
Exploratory Outcome To determine if there is a difference in cost between induction of labor in women with an unfavorable cervix with the use of oral misoprostol versus intravenous oxytocin.
Hypothesis: The use of oral misoprostol will be cost effective in women presenting with PROM and an unfavorable cervix.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral misoprostol | Active comparator | Drug: Misoprostol Oral ProductAt time of delivery, participants randomly assigned to either oral misoprostol will receive 50 mcg of Misoprostol every 4 hours up to 6 doses, OR until simplified Bishop score >6 (whichever is achieved first). |
| intravenous oxytocin | Active comparator | Drug: Intravenous OxytocinAt time of delivery, participants randomly assigned to intravenous oxytocin, will be administered the drug per standard of labor and delivery titrations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Early Term to late term pregnancy (>37 weeks and 0 days and <42 weeks and 0 days)
- Late Preterm Pregnancy (34 weeks and 0 days and <37 weeks)
- Confirmed rupture of membranes by either sterile speculum exam or AmniSure
- Simplified Bishop Score ≤ 6
- Maternal Age > 18 years old
Key exclusion criteria (6 listed)
- Concern for intra-amniotic infection
- Previous Cesarean delivery
- Lack of appropriate dating criteria for the pregnancy
- Inability to give informed consent in the patient's native language
- Known bleeding disorder such as von Willebrand's disease or hemophilia
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 |
|---|---|---|
| Misoprostol Oral ProductAlso: Oral ProductMisoprostol will be dosed using the preexisting UnityPoint Health-Meriter Protocol for oral misoprostol administration. | Drug | oral misoprostol |
| Intravenous OxytocinAlso: IV ProductIntravenous oxytocin administration will also follow standard, UnityPoint Health-Meriter Protocol. | Drug | intravenous oxytocin |
Primary outcome
Primary Endpoint: Time from initial medication administration to vaginal delivery
Time frame: Up to 72 hours
time from initiation of induction of labor to vaginal delivery in women with an unfavorable cervix with the use of oral misoprostol versus intravenous oxytocin
5 secondary outcomes
Secondary endpoint 1: Rate of Postpartum Hemorrhage
Time frame: up to 24 hours for immediate postpartum hemorrhage
Secondary endpoint 2: Rate of Suspected or Confirmed Intrapartum Intramniotic Infection
Time frame: Prior to delivery
Secondary endpoint 3: Rate of Suspected Endometritis
Time frame: From delivery to 6 weeks postpartum
Secondary endpoint 4: Rate of Infectious Morbidity for Neonates
Time frame: up to 6 weeks of life
Secondary endpoint 5: Participant Satisfaction as Measured by modified Labour Agentry Scale
Time frame: Postpartum day one with repeat instrument at 6 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- 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.
Jacquelyn Adams, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Misoprostol Oral Product and Intravenous Oxytocin in people with Premature Rupture of Membrane and Induction of Labor Affected Fetus / Newborn, run by University of Wisconsin, Madison at 1 site in United States.
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 7 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: finished, as of the sponsor's last update on 28 Aug 2025. 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary Endpoint: Time from initial medication administration to vaginal delivery (time frame: Up to 72 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 28 Aug 2025.