Who is sponsoring NCT05262738?

NCT05262738 is sponsored by University of Texas at Austin.

What drugs are being tested in NCT05262738?

Interventions in NCT05262738: 50 Micrograms Vaginal Misoprostol (Intervention), 25 Micrograms Vaginal Misoprostol (Control).

What condition does NCT05262738 study?

NCT05262738 studies Pregnancy Related, Obesity, Labor Onset and Length Abnormalities.

Is NCT05262738 still recruiting?

NCT05262738 is currently completed. Last updated 3 July 2024.

Are results published for NCT05262738?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-07-03 · How we verify

NCT05262738: MD30 RCT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Misoprostol Dosing in BMI Greater Than 30

Completed Phase 4 Results posted Last updated 3 July 2024

What this trial tests

Phase 4 trial testing 50 Micrograms Vaginal Misoprostol (Intervention) in Pregnancy Related in 180 participants. Completed in 17 July 2023.

Timeline

1 June 2022

Primary endpoint
14 July 2023

17 July 2023

Quick facts

Lead sponsor	University of Texas at Austin
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	180
Start date	1 June 2022
Primary completion	14 July 2023
Estimated completion	17 July 2023
Sites	1 location across United States

Drugs / interventions tested

50 Micrograms Vaginal Misoprostol (Intervention) — full drug profile →
25 Micrograms Vaginal Misoprostol (Control) — full drug profile →

Conditions studied

Pregnancy Related — all drugs for Pregnancy Related →
Obesity — all drugs for Obesity →
Labor Onset and Length Abnormalities — all drugs for Labor Onset and Length Abnormalities →

Sponsor

University of Texas at Austin

Who can join

18 and older, female only, with Pregnancy Related or Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Interval Time From Labor Induction Initiation to Delivery (Vaginal or Cesarean) Primary · From baseline to the time of delivery (baseline is initiation of labor induction), up to 3 days

Group	Value	95% CI
50 Micrograms Vaginal Misoprostol (Intervention)	18.56	± 9.92
25 Micrograms Vaginal Misoprostol (Control)	21.59	± 11.11

Interval Time From Labor Induction to Vaginal Delivery Secondary · From baseline (baseline is initiation of labor induction) to the time of vaginal delivery, up to 3 days

Group	Value	95% CI
50 Micrograms Vaginal Misoprostol (Intervention)	17.20	± 9.22
25 Micrograms Vaginal Misoprostol (Control)	19.00	± 10.76

Number of Cesarean Deliveries Secondary · Assessed following delivery, through study completion which is estimated at 1 year.

Group	Value	95% CI
50 Micrograms Vaginal Misoprostol (Intervention)	25
25 Micrograms Vaginal Misoprostol (Control)	24

Number of Participants Exhibiting Uterine Tachysystole Secondary · Assessed 4 hours post-misoprostol placement

Tachysystole is defined as greater than or equal to 5 contractions within a 10 minute period

Group	Value	95% CI
50 Micrograms Vaginal Misoprostol (Intervention)	20
25 Micrograms Vaginal Misoprostol (Control)	9

Number of Participants Exhibiting Uterine Tachysystole With Fetal Decelerations Secondary · Assessed 4 hours post-misoprostol placement

Tachysystole is defined as greater than or equal to 5 contractions within a 10 minute period. Decelerations are defined by the 2008 NICHD Fetal Monitoring Terminology.

Group	Value	95% CI
50 Micrograms Vaginal Misoprostol (Intervention)	2
25 Micrograms Vaginal Misoprostol (Control)	2

Number of Participants Receiving Terbutaline Secondary · From baseline to the time of delivery

Group	Value	95% CI
50 Micrograms Vaginal Misoprostol (Intervention)	2
25 Micrograms Vaginal Misoprostol (Control)	1

Number of Participants Diagnosed With Clinical Chorioamnionitis Secondary · From baseline to the time of delivery

Group	Value	95% CI
50 Micrograms Vaginal Misoprostol (Intervention)	8
25 Micrograms Vaginal Misoprostol (Control)	10

Number of Participants Diagnosed With Postpartum Hemorrhage Secondary · Assessed at time of delivery

Group	Value	95% CI
50 Micrograms Vaginal Misoprostol (Intervention)	12
25 Micrograms Vaginal Misoprostol (Control)	17

Patient Satisfaction Six Simple Questions, Question 1 Secondary · Assessed postpartum day one following delivery, up to 5 days post-delivery.

Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 1: Experience has shown that I can have appropriate and adequate control over my care. 1=strongly disagree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1

Group	Value	95% CI
50 Micrograms Vaginal Misoprostol (Intervention)	6	6 – 7
25 Micrograms Vaginal Misoprostol (Control)	6	6 – 7

Patient Satisfaction Six Simple Questions, Question 2 Secondary · Assessed postpartum day one following delivery, up to 5 days post-delivery.

Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 2: The person(s) responsible for my care are/were caring and compassionate. 1=strongly disagree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1

Group	Value	95% CI
50 Micrograms Vaginal Misoprostol (Intervention)	7	6 – 7
25 Micrograms Vaginal Misoprostol (Control)	7	6 – 7

Patient Satisfaction Six Simple Questions, Question 3 Secondary · Assessed postpartum day one following delivery, up to 5 days post-delivery.

Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 3: Problems that have arisen up to now have not been dealt with effectively. 1=strongly disagree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1

Group	Value	95% CI
50 Micrograms Vaginal Misoprostol (Intervention)	2	1 – 4
25 Micrograms Vaginal Misoprostol (Control)	2	1 – 4

Patient Satisfaction Six Simple Questions, Question 4 Secondary · Assessed postpartum day one following delivery, up to 5 days post-delivery.

Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 4: My needs have been addressed with appropriate consideration for my time. 1=strongly disagree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1

Group	Value	95% CI
50 Micrograms Vaginal Misoprostol (Intervention)	6	6 – 7
25 Micrograms Vaginal Misoprostol (Control)	7	6 – 7

Adverse events — posted to ClinicalTrials.gov

Time frame: through study completion, an average of 1 week.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

50 Micrograms Vaginal Misoprostol (Intervention)

Serious: 2/91 (2%)

Deaths: 0/91

25 Micrograms Vaginal Misoprostol (Control)

Serious: 5/88 (6%)

Deaths: 0/88

Serious adverse events (2 terms)

Reaction	System	50 Micrograms Vaginal Miso…	25 Micrograms Vaginal Miso…
Neonatal ICU Admission	Pregnancy, puerperium and perinatal conditions	—	—
Maternal ICU admission	Pregnancy, puerperium and perinatal conditions	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	50 Micrograms Vaginal Miso…	25 Micrograms Vaginal Miso…
postpartum hemorrhage	Pregnancy, puerperium and perinatal conditions	—	—
clinical endometritis	Pregnancy, puerperium and perinatal conditions	—	—
pRBC transfusion	Blood and lymphatic system disorders	—	—
wound complication	Surgical and medical procedures	—	—
sepsis	Infections and infestations	—	—

Most-reported serious reactions: Neonatal ICU Admission, Maternal ICU admission.

Data from ClinicalTrials.gov NCT05262738 adverse events section.

Sponsor's own description

The investigators are performing a randomized controlled-trial investigating if 50mcg (compared to 25 mcg) of vaginal misoprostol reduces the time from induction start to delivery in obese women.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other University of Texas at Austin trials

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05262738 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Texas at Austin
Last refreshed: 3 July 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05262738.

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