ObesityPhase 4CROWNNCT02639429
Cervical Ripening for Obese Women: A Randomized, Comparative Effectiveness Trial
A Phase 4 study testing Vaginal Misoprostol and Foley Balloon + Vaginal Misoprostol in people with Obesity and Labor Induction, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
Obese pregnant women (BMI ≥ 30 kg/m2) are more likely than their normal-weight counterparts to require induction of labor because of increased rates of obstetric complications including pregnancy related hypertensive disorders, diabetes, and prolonged gestations. 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
- Obesity, Labor Induction, Cesarean Delivery
- What is being tested?
- Vaginal Misoprostol and Foley Balloon + Vaginal Misoprostol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 24 Jun 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Nulliparous women aged 18 or above
- BMI ≥ 30 at the time of labor induction
- Singleton gestation
- Cephalic presentation (includes successful external cephalic version)
- Intact fetal membranes
- Unfavorable cervix (Bishop score of ≤ 6)
- Gestational age ≥ 32 weeks
Who cannot join
- Patient not candidate for IOL with misoprostol as deemed by the treating physician
- Multiple gestation
- Major fetal anomalies
- Fetal demise
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center
Houston, Texas, 77030
About this study
Official title: The Efficacy of Transcervical Foley Balloon Plus Vaginal Misoprostol Versus Vaginal Misoprostol Alone For Cervical Ripening In Nulliparous Obese Women: A Randomized, Comparative Effectiveness Trial
Obese pregnant women (BMI ≥ 30 kg/m2) are more likely than their normal-weight counterparts to require induction of labor because of increased rates of obstetric complications including pregnancy related hypertensive disorders, diabetes, and prolonged gestations. Several studies have shown that obese women experience increased labor duration and oxytocin needs when compared to normal-weight women. This in turn results in increased rates for unplanned cesarean delivery (CD) as a result of failed induction of labor (IOL), arrest disorders and non-reassuring fetal heart rate tracing, that is dose-dependent with increasing class of obesity. The investigators hypothesize that obese pregnant women and unfavorable cervix (Bishop score ≤ 6), IOL ≥ 24 weeks gestation using the Foley balloon plus vaginal misoprostol will result in reduced cesarean delivery rates when compared to vaginal misoprostol alone.
Read the detailed description
Nulliparous pregnant women at ≥ 32 weeks' gestation admitted to labor and delivery for IOL and who meet the inclusion and exclusion criteria will be approached by the research staff. Group 1 will be composed of women allocated to the Foley balloon plus misoprostol. These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team.
Group 2 will be composed of women allocated to vaginal misoprostol-only. These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Similarly, further management will be left at the discretion of the labor team.
In both groups, if IV oxytocin is indicated, it will be withheld until 4 hours after the last dose of misoprostol to prevent uterine hyperstimulation. Other aspects of labor management will be similar for both groups, including continuous electronic fetal monitoring with external Doppler device or fetal scalp electrode. Uterine contraction assessment will be performed with either an external tocodynamometer or an intrauterine pressure catheter.
- Conditions
- Obesity, Labor Induction, Cesarean Delivery
- Being tested
- Vaginal Misoprostol, Foley Balloon + Vaginal Misoprostol
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal MisoprostolDrug
Also called Cytotec
Foley Balloon + Vaginal MisoprostolDevice
| Study group | Role | What they receive |
|---|---|---|
| Combined approach: Foley Balloon + Vaginal Misoprostol | Experimental | These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team. Receives: Device: Foley Balloon + Vaginal Misoprostol |
| Single approach: Vaginal Misoprostol only | Active comparator | These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team. Receives: Drug: Vaginal Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Need for Cesarean Delivery
Measured: Induction to delivery
Secondary outcomes (14)
Indication for Cesarean Delivery
Categories of Indications for Cesarean Delivery:
- = Cephalopelvic disproportion
- = Failed induction/Failure to progress
- = Cord prolapse
- = Non-reassuring fetal tracing
- = Malpresentation
- = Placental abruption
- = Other
Measured: Induction to delivery
Induction-to-delivery Interval in Hours
Measured: Induction to delivery
Number of Participants With a Need for Oxytocin Augmentation
Measured: Induction to delivery
Number of Participants Exhibiting Tachysystole Resulting in Fetal Heart Rate Abnormalities
Uterine tachysystole is a condition of excessively frequent uterine contractions during pregnancy. Tachysystole is indicated ≥ 5 contractions in a 10 minute period averaged over a 30-minute window.
Measured: Induction to delivery
Number of Participants With Clinical Chorioamnionitis
Clinical chorioamnionitis is indicated by maternal fever ≥ 100.4 Fahrenheit, uterine fundal tenderness, maternal or fetal tachycardia (>100/min and >160/min, respectively), and purulent or foul amniotic fluid.
Measured: Induction to delivery
Number of Participants With a Need for Operative Vaginal Delivery
Measured: Induction to delivery
Composite Maternal Morbidity as Indicated by the Number of Participants With Measures of Maternal Morbidity
Measures of maternal morbidity assessed:
- Maternal ICU admission
- Postpartum endometritis
- Surgical-site infections prior to discharge
- Venous thromboembolism
- Need for transfusion
- Maternal death
Measured: Induction to discharge (approximately 5 days)
Number of Newborns Admitted to the Neonatal Intensive Care Unit (NICU)
Measured: From delivery to neonatal discharge (approximately 2 to 7 days)
Number of Newborns With Transient Tachypnea (TTN)
Measured: From delivery to neonatal discharge (approximately 2 to 7 days)
Number of Newborns With Respiratory Distress Syndrome (RDS)
Measured: From delivery to neonatal discharge (approximately 2 to 7 days)
Number of Newborns With Meconium Aspiration Syndrome
Measured: From delivery to neonatal discharge (approximately 2 to 7 days)
Number of Newborns With Culture-proven Sepsis
Measured: From delivery to neonatal discharge (approximately 2 to 7 days)
Number of Newborns With Seizures
Measured: From delivery to neonatal discharge (approximately 2 to 7 days)
Composite Neonatal Morbidity as Indicated by the Number of Newborns With Measures of Neonatal Morbidity
Measures of neonatal morbidity assessed:
- Apgar score ≤ 7 at 5 mins
- Umbilical cord potential of hydrogen (pH) < 7.1
- Neonatal injury: brachial plexus injury, fracture
- Perinatal death
Measured: From delivery to neonatal discharge (approximately 2 to 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2015 (estimated)
- Study startJan 2016
- Primary completion24 Jun 2018
- Study completion24 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesk A.Jawad Alrais, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639429
- Sponsor's protocol ID
- HSC-MS-15-0895
- Acronym
- CROWN
- Status last verified
- Aug 2019
- First submitted
- 15 Dec 2015
- Last updated
- 26 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
PubMed 36996264Viteri OA, Tabsh KK, Alrais MA, Salazar XC, Lopez JM, Fok RY, Chauhan SP, Sibai BM. Transcervical Foley Balloon Plus Vaginal Misoprostol versus Vaginal Misoprostol Alone for Cervical Ripening in Nulliparous Obese Women: A Multicenter, Randomized, Comparative-Effectiveness Trial. Am J Perinatol. 2021 Aug;38(S 01):e123-e128. doi: 10.1055/s-0040-1708805. Epub 2020 Apr 16.
PubMed 32299108
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Transcervical Foley Balloon Plus Vaginal Misoprostol Versus Vaginal Misoprostol Alone For Cervical Ripening In Nulliparous Obese Women: A Randomized, Comparative Effectiveness Trial
- ClinicalTrials.gov ID
- NCT02639429
- Acronym / sponsor ID
- CROWN / HSC-MS-15-0895
- Conditions
- Obesity, Labor Induction, Cesarean Delivery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 24 Jun 2018 (actual)
- Study completion
- 24 Jun 2018 (actual)
- First posted
- 24 Dec 2015 (estimated)
- Results
- Posted 26 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obese pregnant women (BMI ≥ 30 kg/m2) are more likely than their normal-weight counterparts to require induction of labor because of increased rates of obstetric complications including pregnancy related hypertensive disorders, diabetes, and prolonged gestations. Several studies have shown that obese women experience increased labor duration and oxytocin needs when compared to normal-weight women. This in turn results in increased rates for unplanned cesarean delivery (CD) as a result of failed induction of labor (IOL), arrest disorders and non-reassuring fetal heart rate tracing, that is dose-dependent with increasing class of obesity. The investigators hypothesize that obese pregnant women and unfavorable cervix (Bishop score ≤ 6), IOL ≥ 24 weeks gestation using the Foley balloon plus vaginal misoprostol will result in reduced cesarean delivery rates when compared to vaginal misoprostol alone.
Detailed description
Nulliparous pregnant women at ≥ 32 weeks' gestation admitted to labor and delivery for IOL and who meet the inclusion and exclusion criteria will be approached by the research staff. Group 1 will be composed of women allocated to the Foley balloon plus misoprostol. These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team.
Group 2 will be composed of women allocated to vaginal misoprostol-only. These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Similarly, further management will be left at the discretion of the labor team.
In both groups, if IV oxytocin is indicated, it will be withheld until 4 hours after the last dose of misoprostol to prevent uterine hyperstimulation. Other aspects of labor management will be similar for both groups, including continuous electronic fetal monitoring with external Doppler device or fetal scalp electrode. Uterine contraction assessment will be performed with either an external tocodynamometer or an intrauterine pressure catheter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined approach: Foley Balloon + Vaginal Misoprostol | Experimental | Device: Foley Balloon + Vaginal MisoprostolThese women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team. |
| Single approach: Vaginal Misoprostol only | Active comparator | Drug: Vaginal MisoprostolThese women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score > 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Nulliparous women aged 18 or above
- BMI ≥ 30 at the time of labor induction
- Singleton gestation
- Cephalic presentation (includes successful external cephalic version)
- Intact fetal membranes
Key exclusion criteria (4 listed)
- Patient not candidate for IOL with misoprostol as deemed by the treating physician
- Multiple gestation
- Major fetal anomalies
- Fetal demise
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 |
|---|---|---|
| Vaginal MisoprostolAlso: Cytotec | Drug | Single approach: Vaginal Misoprostol only |
| Foley Balloon + Vaginal Misoprostol | Device | Combined approach: Foley Balloon + Vaginal Misoprostol |
Primary outcome
Number of Participants With a Need for Cesarean Delivery
Time frame: Induction to delivery
14 secondary outcomes
Indication for Cesarean Delivery
Time frame: Induction to delivery
Induction-to-delivery Interval in Hours
Time frame: Induction to delivery
Number of Participants With a Need for Oxytocin Augmentation
Time frame: Induction to delivery
Number of Participants Exhibiting Tachysystole Resulting in Fetal Heart Rate Abnormalities
Time frame: Induction to delivery
Number of Participants With Clinical Chorioamnionitis
Time frame: Induction to delivery
Number of Participants With a Need for Operative Vaginal Delivery
Time frame: Induction to delivery
Composite Maternal Morbidity as Indicated by the Number of Participants With Measures of Maternal Morbidity
Time frame: Induction to discharge (approximately 5 days)
Number of Newborns Admitted to the Neonatal Intensive Care Unit (NICU)
Time frame: From delivery to neonatal discharge (approximately 2 to 7 days)
Number of Newborns With Transient Tachypnea (TTN)
Time frame: From delivery to neonatal discharge (approximately 2 to 7 days)
Number of Newborns With Respiratory Distress Syndrome (RDS)
Time frame: From delivery to neonatal discharge (approximately 2 to 7 days)
Number of Newborns With Meconium Aspiration Syndrome
Time frame: From delivery to neonatal discharge (approximately 2 to 7 days)
Number of Newborns With Culture-proven Sepsis
Time frame: From delivery to neonatal discharge (approximately 2 to 7 days)
Number of Newborns With Seizures
Time frame: From delivery to neonatal discharge (approximately 2 to 7 days)
Composite Neonatal Morbidity as Indicated by the Number of Newborns With Measures of Neonatal Morbidity
Time frame: From delivery to neonatal discharge (approximately 2 to 7 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36996264de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
- Derived from this study: PubMed 32299108Viteri OA, Tabsh KK, Alrais MA, Salazar XC, Lopez JM, Fok RY, Chauhan SP, Sibai BM. Transcervical Foley Balloon Plus Vaginal Misoprostol versus Vaginal Misoprostol Alone for Cervical Ripening in Nulliparous Obese Women: A Multicenter, Randomized, Comparative-Effectiveness Trial. Am J Perinatol. 2021 Aug;38(S 01):e123-e128. doi: 10.1055/s-0040-1708805. Epub 2020 Apr 16.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vaginal Misoprostol and Foley Balloon + Vaginal Misoprostol in people with Obesity and Labor Induction, run by The University of Texas Health Science Center, Houston 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 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: finished, as of the sponsor's last update on 26 Aug 2019. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With a Need for Cesarean Delivery (time frame: Induction to delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02639429, which also lists 2 linked publications.
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 26 Aug 2019.