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TerminatedNCT02777190Updated Oct 13, 2022Results posted

A Comparison of Oral Misoprostol and Vaginal Misoprostol for Cervical Ripening and Induction of Labor

A Phase 4 interventional study of Misoprostol in Labor; Forced or Induced, Affecting Fetus or Newborn and Pregnancy, sponsored by Milton S. Hershey Medical Center. Terminated at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-13.

Sponsored by Milton S. Hershey Medical Center · Phase 4, Interventional, and Treatment

Why this study was terminated
Insufficient research staff to recruit and complete study
Phase
Phase 4
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

The purpose of this study is to study if misoprostol administered orally is at least as effective as misoprostol administered vaginally for cervical ripening and the induction of labor. The main purpose is to show that oral misoprostol administration is non-inferior to vaginal misoprostol administration with respect to the time interval from misoprostol administration to onset of active phase of labor. The study is a non-inferiority, prospective randomized controlled trial comparing oral misoprostol given as 25 mcg every 2 hours versus vaginal misoprostol given as 25 mcg every 4 hours.

02

Conditions studied

  • Labor; Forced or Induced, Affecting Fetus or Newborn
  • Pregnancy

Keywords

  • misoprostol
  • cytotec
  • cervical ripening
  • labor, induced
  • active labor
03

In context

Lead sponsor

Milton S. Hershey Medical Center is the lead sponsor of 491 studies on the registry; 59 are open to participants now.

Of its 58 completed or terminated interventional studies of FDA-regulated products, 44 (76%) have results posted.

Browse Milton S. Hershey Medical Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Pregnant Female Patients greater than or equal to 18 years of age
  2. Induction of labor for a single live intrauterine pregnancy
  3. Greater than or equal to 37 weeks gestational age
  4. Cephalic presentation
  5. 20 minute reassuring fetal heart rate (reactive nonstress test (NST))
  6. Bishop score based on sterile vaginal exam of less than or equal to 6, for which the cervical dilation is less than or equal to 2 cm.
  7. Equal to 3 or less uterine contractions over 10 minutes

Exclusion criteria

Exclusion Criteria:

  1. Previous uterine scar
  2. Contraindication to vaginal delivery
  3. Patients with preeclampsia
  4. Grand multiparty - greater than or equal to 5 live births or stillbirths
  5. Premature rupture of membranes
  6. Suspected intrauterine growth restriction
  7. Fetal anomalies
  8. Contraindication to misoprostol (history of allergy to prostaglandins, glaucoma)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Oral misoprostol

    oral misoprostol given 25 mcg every 2 hours

    Drug: Misoprostol

  • Active comparator
    Vaginal misoprostol

    vaginal misoprostol given 25 mcg every 4 hours

    Drug: Misoprostol

Interventions

  • DrugMisoprostol

    Comparing dosing of misoprostol 25 mcg orally every 2 hours versus 25 mcg vaginally every 4 hours.

    Also known as: Cytotec

06

What researchers measure

Primary outcomes

  1. Time to Active Labor

    Active phase of labor defined as greater than or equal to 6 cm cervical dilation

    Time frame: from start of induction of labor (first misoprostol administration) to active phase of labor, up to 3 days.

Secondary outcomes

  1. Time to Initiation of Oxytocin for Labor Augmentation

    The length of time (in hours) between the administration of misoprostol (first dose) and the first administration of oxytocin for labor augmentation.

    Time frame: From start of induction of labor (first misoprostol administration) to initiation of oxytocin for labor augmentation, up to 36 hours

  2. Time to Vaginal Delivery

    includes vaginal deliveries only; cesarean section deliveries are excluded

    Time frame: from start of induction of labor (first misoprostol administration) to vaginal delivery, up to 3 days

  3. Cesarean Section Rate

    Number of cesarean sections/total deliveries (%)

    Time frame: From enrollment until delivery, up to 3 days

  4. Rate of Tachysystole

    Tachysystole is defined as 4 or more contractions in a 10 minute period.

    Time frame: from enrollment until delivery, up to 3 days

  5. Rate of Tachysystole Causing Non-reassuring Fetal Heart Tones

    Previously defined as "hyperstimulation", this outcome measure is defined as 4 or more contractions in a 10 minute period (tachysystole) thought to be causing recurrent variable or late decelerations, bradycardia, or minimal variability in the fetal heart rate tracing (non-reassuring fetal heart tones,which would require intervention to resolve or delivery of the infant).

    Time frame: From enrollment until delivery, up to 3 days

  6. Rate of Need for Tocolysis

    Tocolysis is the administration of medication to decrease or stop contractions.

    Time frame: from enrollment until delivery, up to 3 days

  7. Rate of Chorioamnionitis

    Chorioamnionitis is defined as an intraamniotic infection.

    Time frame: from enrollment until delivery, up to 3 days

  8. Rate of Meconium Stained Fluid

    Amniotic fluid with visible meconium (from fetal defecation) within it.

    Time frame: from enrollment until delivery, up to 3 days

  9. Neonatal Morbidity

    binary composite outcome defined as Apgar score \< 7, or cord blood gas pH of less than 7 or base deficit great than 12, or neonatal intensive care unit admission within 4 hours of delivery.

    Time frame: 4 hours from delivery

  10. Rate of Anti-emetic Use

    Use of medication to treat nausea.

    Time frame: from enrollment until delivery, up to 3 days

  11. Rate of Vaginal Delivery Within 24 Hours

    Vaginal delivery within from start of induction with misoprostol.

    Time frame: 24 hours from start of induction of labor (first misoprostol administration)

  12. Rate of Abandoning Misoprostol for Cervical Ripening and Switching to Mechanical Dilation for Cervical Ripening

    Based on clinician's judgment on the progress of the induction, the rate that misoprostol administration was stopped and a cervical ripening balloon was used instead

    Time frame: from enrollment until delivery, up to 3 days

07

Results

Posted Oct 13, 2022
Limitations and caveats
Limitations include that during the COVID-19 pandemic, all in person research was suspended. Research time was reallocated to clinical time for providers. Recruitment was difficult. We had multiple changes in the research team requiring retraining. Ultimately, we were not able to recruit the numbers needed so the trial was terminated with inadequate numbers of subjects analyzed. Multiple turnovers led to a delay in completing our close out.

Participant flow

Participant flow — Overall Study
MilestoneOral MisoprostolVaginal Misoprostol
Started1717
Completed1611
Not completed16

Outcome measures

PrimaryTime to Active Labor

Active phase of labor defined as greater than or equal to 6 cm cervical dilation

Time frame:
from start of induction of labor (first misoprostol administration) to active phase of labor, up to 3 days.
Reported as:
Mean · hours
Time to Active Labor
hoursOral MisoprostolVaginal Misoprostol
Time to Active Labor19.8 ± 10.621.4 ± 10.3
Statistical analysis
  • Oral Misoprostol vs Vaginal Misoprostol · t-test, 1 sided · p = 0.09 · Mean difference (final values): -1.7Difference calculated as oral minus vaginal
SecondaryTime to Initiation of Oxytocin for Labor Augmentation

The length of time (in hours) between the administration of misoprostol (first dose) and the first administration of oxytocin for labor augmentation.

Time frame:
From start of induction of labor (first misoprostol administration) to initiation of oxytocin for labor augmentation, up to 36 hours
Reported as:
Mean · hours
Time to Initiation of Oxytocin for Labor Augmentation
hoursOral MisoprostolVaginal Misoprostol
Time to Initiation of Oxytocin for Labor Augmentation11.0 ± 6.812.6 ± 6.8
Statistical analysis
  • Oral Misoprostol vs Vaginal Misoprostol · t-test, 2 sided · p = 0.54
SecondaryTime to Vaginal Delivery

includes vaginal deliveries only; cesarean section deliveries are excluded

Time frame:
from start of induction of labor (first misoprostol administration) to vaginal delivery, up to 3 days
Reported as:
Mean · hours
Time to Vaginal Delivery
hoursOral MisoprostolVaginal Misoprostol
Time to Vaginal Delivery22.3 ± 11.123.2 ± 9.7
Statistical analysis
  • Oral Misoprostol vs Vaginal Misoprostol · t-test, 2 sided · p = 0.64
SecondaryCesarean Section Rate

Number of cesarean sections/total deliveries (%)

Time frame:
From enrollment until delivery, up to 3 days
Reported as:
Count of participants · Participants
Cesarean Section Rate
ParticipantsOral MisoprostolVaginal Misoprostol
Cesarean Section Rate27
Statistical analysis
  • Oral Misoprostol vs Vaginal Misoprostol · Fisher Exact · p = 0.12
SecondaryRate of Tachysystole

Tachysystole is defined as 4 or more contractions in a 10 minute period.

Time frame:
from enrollment until delivery, up to 3 days
Reported as:
Count of participants · Participants
Rate of Tachysystole
ParticipantsOral MisoprostolVaginal Misoprostol
Rate of Tachysystole14
Statistical analysis
  • Oral Misoprostol vs Vaginal Misoprostol · Fisher Exact · p = 0.34
SecondaryRate of Tachysystole Causing Non-reassuring Fetal Heart Tones

Previously defined as "hyperstimulation", this outcome measure is defined as 4 or more contractions in a 10 minute period (tachysystole) thought to be causing recurrent variable or late decelerations, bradycardia, or minimal variability in the fetal heart rate tracing (non-reassuring fetal heart tones,which would require intervention to resolve or delivery of the infant).

Time frame:
From enrollment until delivery, up to 3 days
Reported as:
Count of participants · Participants
Rate of Tachysystole Causing Non-reassuring Fetal Heart Tones
ParticipantsOral MisoprostolVaginal Misoprostol
Rate of Tachysystole Causing Non-reassuring Fetal Heart Tones12
Statistical analysis
  • Oral Misoprostol vs Vaginal Misoprostol · Fisher Exact · p = 1.00
SecondaryRate of Need for Tocolysis

Tocolysis is the administration of medication to decrease or stop contractions.

Time frame:
from enrollment until delivery, up to 3 days
Reported as:
Count of participants · Participants
Rate of Need for Tocolysis
ParticipantsOral MisoprostolVaginal Misoprostol
Rate of Need for Tocolysis12
Statistical analysis
  • Oral Misoprostol vs Vaginal Misoprostol · Fisher Exact · p = 0.60
SecondaryRate of Chorioamnionitis

Chorioamnionitis is defined as an intraamniotic infection.

Time frame:
from enrollment until delivery, up to 3 days
Reported as:
Count of participants · Participants
Rate of Chorioamnionitis
ParticipantsOral MisoprostolVaginal Misoprostol
Rate of Chorioamnionitis00
SecondaryRate of Meconium Stained Fluid

Amniotic fluid with visible meconium (from fetal defecation) within it.

Time frame:
from enrollment until delivery, up to 3 days
Reported as:
Count of participants · Participants
Rate of Meconium Stained Fluid
ParticipantsOral MisoprostolVaginal Misoprostol
Rate of Meconium Stained Fluid24
Statistical analysis
  • Oral Misoprostol vs Vaginal Misoprostol · Fisher Exact · p = 0.40
SecondaryNeonatal Morbidity

binary composite outcome defined as Apgar score \< 7, or cord blood gas pH of less than 7 or base deficit great than 12, or neonatal intensive care unit admission within 4 hours of delivery.

Time frame:
4 hours from delivery
Reported as:
Count of participants · Participants
Neonatal Morbidity
ParticipantsOral MisoprostolVaginal Misoprostol
Neonatal Morbidity23
Statistical analysis
  • Oral Misoprostol vs Vaginal Misoprostol · Fisher Exact · p = 1.00
SecondaryRate of Anti-emetic Use

Use of medication to treat nausea.

Time frame:
from enrollment until delivery, up to 3 days
Reported as:
Count of participants · Participants
Rate of Anti-emetic Use
ParticipantsOral MisoprostolVaginal Misoprostol
Rate of Anti-emetic Use71
Statistical analysis
  • Oral Misoprostol vs Vaginal Misoprostol · Fisher Exact · p = 0.04
SecondaryRate of Vaginal Delivery Within 24 Hours

Vaginal delivery within from start of induction with misoprostol.

Time frame:
24 hours from start of induction of labor (first misoprostol administration)
Reported as:
Count of participants · Participants
Rate of Vaginal Delivery Within 24 Hours
ParticipantsOral MisoprostolVaginal Misoprostol
Rate of Vaginal Delivery Within 24 Hours106
Statistical analysis
  • Oral Misoprostol vs Vaginal Misoprostol · Fisher Exact · p = 1.00
SecondaryRate of Abandoning Misoprostol for Cervical Ripening and Switching to Mechanical Dilation for Cervical Ripening

Based on clinician's judgment on the progress of the induction, the rate that misoprostol administration was stopped and a cervical ripening balloon was used instead

Time frame:
from enrollment until delivery, up to 3 days
Reported as:
Count of participants · Participants
Rate of Abandoning Misoprostol for Cervical Ripening and Switching to Mechanical Dilation for Cervical Ripening
ParticipantsOral MisoprostolVaginal Misoprostol
Rate of Abandoning Misoprostol for Cervical Ripening and Switching to Mechanical Dilation for Cervical Ripening27
Statistical analysis
  • Oral Misoprostol vs Vaginal Misoprostol · Fisher Exact · p = 0.12

Adverse events

Collected over During hospital stay-admission for induction until discharge after delivery, up to 7 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Oral Misoprostol0/17 (0%)0/17 (0%)1/17 (5.9%)
Vaginal Misoprostol0/17 (0%)0/17 (0%)1/17 (5.9%)
Most frequent other events
Most frequent other events
EventOral MisoprostolVaginal Misoprostol
Neonatal NICU admissionPregnancy, puerperium and perinatal conditions1/171/17

Baseline characteristics

Age, Continuous
Age, Continuous(years)Oral MisoprostolVaginal MisoprostolTotal
Mean27.8 ± 4.326.5 ± 5.727.2 ± 5.0
Sex: Female, Male
Sex: Female, Male(Participants)Oral MisoprostolVaginal MisoprostolTotal
Female171734
Male000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Oral MisoprostolVaginal MisoprostolTotal
Hispanic or Latino011
Not Hispanic or Latino171633
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Oral MisoprostolVaginal MisoprostolTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American336
White131326
More than one race000
Unknown or Not Reported112
08

Study locations

1 site
  • Penn State Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
09

References and documents

Publications

  • Kerr RS, Kumar N, Williams MJ, Cuthbert A, Aflaifel N, Haas DM, Weeks AD. Low-dose oral misoprostol for induction of labour. Cochrane Database Syst Rev. 2021 Jun 22;6(6):CD014484. doi: 10.1002/14651858.CD014484. PubMed 34155622 ↗

Study documents

  • Protocol, analysis plan and consent form · Sep 15, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02777190
Lead sponsor
Milton S. Hershey Medical Center
Responsible party
Jaimey M. Pauli, MD (Principal Investigator, Milton S. Hershey Medical Center) — Principal investigator
First posted
May 19, 2016
Start date
Nov 1, 2017
Primary completion
Apr 23, 2019
Completion
Apr 23, 2019
Results posted
Oct 13, 2022
Last update
Oct 13, 2022

Study contacts

Jaimey Pauli, MD
principal investigator · Milton S. Hershey Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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