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Morbid ObesityEarly Phase 1NCT06199154

Induction of Labor in Morbidly Obese Patients

A Early Phase 1 study testing Misoprostol in people with Morbid Obesity and Pregnancy, run by University of Maryland, Baltimore at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this randomized control trial is to compare different doses of Misoprostol (25 mcg vs 50 mcg) in induction of labor (IOL) in morbidly obese patients with BMI >40. It is known that morbid obesity is a risk factor for failed IOL and ultimately cesarean delivery (CD.) If the rates of vaginal delivery in this… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Morbid Obesity, Pregnancy
What is being tested?
Misoprostol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
1 siteUnited States
Study dates
15 Jul 2024to May 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Morbidly obese (BMI ≥ 40 kg/m2) at admission for induction of labor
  • Speaks English or Spanish
  • Gestational age between 34 weeks and 0 days and 42 weeks and 6 days
  • Age 18 years old or older
  • Viable, single, cephalic fetus
  • Intent to proceed with cervical ripening - cervical exam: dilation < 5 cm
  • Contractions < 5 per 10 minutes

Who cannot join

  • History of cesarean delivery
  • Contraindication to prostaglandin administration (significant myomectomy, prior cesarean delivery)
  • Contraindication to vaginal delivery (placenta previa, vasa previa, HIV with high viral load)
  • Contraindications to labor (cardiac, neurosurgical, need for cesarean)
  • Age < 18yo
  • Fetal growth restriction with abnormal umbilical artery Doppler indices
Show all 12Show fewer
  • Cervical dilation >5 cm
  • Contractions >5 per 10 minutes
  • Significant vaginal bleeding with concern for placental abruption
  • Non-reassuring fetal status or fetal heart rate decelerations
  • Fetal demise or major fetal anomaly
  • Inability to give consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rosa Drummond, MD contact

4103285965

rosa.drummond@umm.edu

Krista Mehlhaff, DO contact

4103285965

KMehlhaff@som.umaryland.edu

United States1 site, 1 recruiting

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

    Rosa Drummond, MD, 410-328-6436, rosa.drummond@umm.edu

    Krista Mehlhaff, DO

    Recruiting

Other trials in United States

About this study

Official title: Induction of Labor in Morbidly Obese Patients: Comparison of 50 mcg and 25 mcg Misoprostol - A Randomized Control Trial

The goal of this randomized control trial is to compare different doses of Misoprostol (25 mcg vs 50 mcg) in induction of labor (IOL) in morbidly obese patients with BMI >40. It is known that morbid obesity is a risk factor for failed IOL and ultimately cesarean delivery (CD.) If the rates of vaginal delivery in this population can improve, then surgical morbidity can be reduced in these patients.

Read the detailed description

The rate of IOL continues to increase, from about 10% in 1990 to 23% in 2018. Patients with BMI >40 are at increased risk for failed IOL and needing a CD. Studies show that morbidly obese patients require higher doses of pitocin and multiple agents to achieve vaginal delivery, but optimal dosing of misoprostol has not been studied as well. Increasing the rate of vaginal delivery in this population will help decrease risk of surgical morbidity.

The investigators plan to conduct a randomized controlled double blinded trial. Patients who are scheduled for induction of labor after 34 weeks gestation, have a BMI >40, and meet all study inclusion criteria will be approached by research personnel during their outpatient appointments. Participants will be randomized to either receive 25 mcg vaginal misoprostol every 4 hours or 50 mcg vaginal misoprostol every 4 hours.

Being tested
Misoprostol
Keywords
induction of labor, morbid obesity, misoprostol
Medical subject headings
Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MisoprostolDrug

    Participants will receive with 25 mcg or 50 mcg vaginal misoprostol every 4 hours.

Study groups in NCT06199154
Study groupRoleWhat they receive
Control - 25 mcg vaginal misoprostolActive comparatorParticipants will receive 25 mcg vaginal misoprostol every 4 hours.
Receives: Drug: Misoprostol
Intervention - 50 mcg vaginal misoprostolExperimentalParticipants will receive 50 mcg vaginal misoprostol every 4 hours.
Receives: Drug: Misoprostol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Achievement of complete cervical dilation

    Measured: Start of IOL until complete dilation

Secondary outcomes (16)

  1. Time interval from start of induction of labor (IOL) to complete cervical dilation

    Measured: Start of IOL until complete dilation

  2. Achievement of 6 cm cervical dilation/active labor

    Measured: Start of IOL until 6 cm dilation

  3. Time interval from start of IOL to 6 cm cervical dilation/active labor

    Measured: Start of IOL until 6 cm dilation

  4. Time interval from start of IOL to vaginal delivery

    Measured: Start of IOL until delivery

  5. Time interval from start of IOL to delivery

    Measured: Start of IOL until delivery

  6. Incidence of vaginal deliveries

    Measured: Start of IOL until delivery

  7. Incidence of cesarean deliveries

    Measured: Start of IOL until delivery

  8. Indication for cesarean delivery

    Maternal or Fetal

    Measured: Start of IOL until delivery

  9. Cervical exam at time of cesarean delivery

    Measured: Start of IOL until delivery

  10. Number of patients with tachysystole

    Measured: Start of IOL until delivery

  11. Number of patients with tachysystole with non reassuring fetal heart rate (NRFHT)

    Measured: Start of IOL until delivery

  12. Number of patients requiring terbutaline

    Measured: Start of IOL until delivery

  13. Number of patients with chorioamnionitis

    Measured: Start of IOL until delivery

  14. Number of patients with postpartum hemorrhage

    Measured: Start of IOL until discharge, assessed up to 4 days

  15. Composite maternal morbidity (need for transfusion, sepsis, ICU admission, death)

    Measured: Start of IOL until postpartum day 4

  16. Composite neonatal morbidity (NICU admission, Apgar score =<7 at 5 minutes, sepsis, cord gas arterial pH <7.10 and/or base deficit < -12, active cooling protocol, death)

    Measured: Start of IOL until discharge or day of life 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2024
  2. Study start15 Jul 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
162 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06199154
Sponsor's protocol ID
HP-00108436
Status last verified
Jul 2026
First submitted
4 Dec 2023
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hoyert, Donna L. "Maternal Mortality Rates in the United States, 2021." Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 16 Mar. 2023, www.cdc.gov/nchs/data/hestat/maternal-mortality/2021/maternal-mortality-rates-2021.htm.

  • MarchofDimes. "Total Cesarean Deliveries by Maternal Race/Ethnicity: United States, 2019-2021 Average." March of Dimes | PeriStats, www.marchofdimes.org/peristats/data?reg=99&top=8&stop=356&lev=1&slev=1&obj=1. Accessed 14 Nov. 2023.

  • "Adult Obesity Facts." Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 17 May 2022, www.cdc.gov/obesity/data/adult.html.

  • Ellis JA, Brown CM, Barger B, Carlson NS. Influence of Maternal Obesity on Labor Induction: A Systematic Review and Meta-Analysis. J Midwifery Womens Health. 2019 Jan;64(1):55-67. doi: 10.1111/jmwh.12935. Epub 2019 Jan 16.

    PubMed 30648804

  • Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 Aug 9;379(6):513-523. doi: 10.1056/NEJMoa1800566.

    PubMed 30089070

  • Beckwith L, Magner K, Kritzer S, Warshak CR. Prostaglandin versus mechanical dilation and the effect of maternal obesity on failure to achieve active labor: a cohort study. J Matern Fetal Neonatal Med. 2017 Jul;30(13):1621-1626. doi: 10.1080/14767058.2016.1220523. Epub 2016 Aug 25.

    PubMed 27560557

  • O'Dwyer V, O'Kelly S, Monaghan B, Rowan A, Farah N, Turner MJ. Maternal obesity and induction of labor. Acta Obstet Gynecol Scand. 2013 Dec;92(12):1414-8. doi: 10.1111/aogs.12263.

    PubMed 24116732

  • Pevzner L, Powers BL, Rayburn WF, Rumney P, Wing DA. Effects of maternal obesity on duration and outcomes of prostaglandin cervical ripening and labor induction. Obstet Gynecol. 2009 Dec;114(6):1315-1321. doi: 10.1097/AOG.0b013e3181bfb39f.

    PubMed 19935035

  • Drummond R, Patel M, Myers M, Ritter A, Hurvitz JA, Goetzinger KR, Crimmins SD. Class III obesity is an independent risk factor for unsuccessful induction of labor. AJOG Glob Rep. 2022 Sep 23;2(4):100109. doi: 10.1016/j.xagr.2022.100109. eCollection 2022 Nov.

    PubMed 36311296

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Misoprostol in people with Morbid Obesity and Pregnancy, run by University of Maryland, Baltimore 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 12 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: looking for participants now, as of the sponsor's last update on 29 Jul 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rosa Drummond, MD (4103285965, rosa.drummond@umm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Achievement of complete cervical dilation (time frame: Start of IOL until complete dilation). 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 NCT06199154, which also lists 9 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 29 Jul 2026.

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