Labor; Forced or Induced, Affecting Fetus or NewbornPhase 4NCT02777190
A Comparison of Oral Misoprostol and Vaginal Misoprostol for Cervical Ripening and Induction of Labor
A Phase 4 study testing Misoprostol in people with Labor; Forced or Induced, Affecting Fetus or Newborn and Pregnancy, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. 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
- Labor; Forced or Induced, Affecting Fetus or Newborn, Pregnancy
- What is being tested?
- Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 23 Apr 2019
- 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
- Pregnant Female Patients greater than or equal to 18 years of age
- Induction of labor for a single live intrauterine pregnancy
- Greater than or equal to 37 weeks gestational age
- Cephalic presentation
- 20 minute reassuring fetal heart rate (reactive nonstress test (NST))
- 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.
- Equal to 3 or less uterine contractions over 10 minutes
Who cannot join
- Previous uterine scar
- Contraindication to vaginal delivery
- Patients with preeclampsia
- Grand multiparty - greater than or equal to 5 live births or stillbirths
- Premature rupture of membranes
- Suspected intrauterine growth restriction
- Fetal anomalies
- Contraindication to misoprostol (history of allergy to prostaglandins, glaucoma)
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
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.
- Being tested
- Misoprostol
- Keywords
- misoprostol, cytotec, cervical ripening, labor, induced, active labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Cytotec
Comparing dosing of misoprostol 25 mcg orally every 2 hours versus 25 mcg vaginally every 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| Oral misoprostol | Experimental | oral misoprostol given 25 mcg every 2 hours Receives: Drug: Misoprostol |
| Vaginal misoprostol | Active comparator | vaginal misoprostol given 25 mcg every 4 hours Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Active Labor
Active phase of labor defined as greater than or equal to 6 cm cervical dilation
Measured: from start of induction of labor (first misoprostol administration) to active phase of labor, up to 3 days.
Secondary outcomes (12)
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.
Measured: From start of induction of labor (first misoprostol administration) to initiation of oxytocin for labor augmentation, up to 36 hours
Time to Vaginal Delivery
includes vaginal deliveries only; cesarean section deliveries are excluded
Measured: from start of induction of labor (first misoprostol administration) to vaginal delivery, up to 3 days
Cesarean Section Rate
Number of cesarean sections/total deliveries (%)
Measured: From enrollment until delivery, up to 3 days
Rate of Tachysystole
Tachysystole is defined as 4 or more contractions in a 10 minute period.
Measured: from enrollment until delivery, up to 3 days
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).
Measured: From enrollment until delivery, up to 3 days
Rate of Need for Tocolysis
Tocolysis is the administration of medication to decrease or stop contractions.
Measured: from enrollment until delivery, up to 3 days
Rate of Chorioamnionitis
Chorioamnionitis is defined as an intraamniotic infection.
Measured: from enrollment until delivery, up to 3 days
Rate of Meconium Stained Fluid
Amniotic fluid with visible meconium (from fetal defecation) within it.
Measured: from enrollment until delivery, up to 3 days
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.
Measured: 4 hours from delivery
Rate of Anti-emetic Use
Use of medication to treat nausea.
Measured: from enrollment until delivery, up to 3 days
Rate of Vaginal Delivery Within 24 Hours
Vaginal delivery within from start of induction with misoprostol.
Measured: 24 hours from start of induction of labor (first misoprostol administration)
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
Measured: from enrollment until delivery, up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study start1 Nov 2017
- Primary completion23 Apr 2019
- Study completion23 Apr 2019
Why it stopped: Insufficient research staff to recruit and complete study
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 (1)Papers the sponsor has linked to this study.
- Other trials for Labor; Forced or Induced, Affecting Fetus or NewbornStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaimey M. Pauli, MD, Milton S. Hershey Medical Center
- Investigators
- Jaimey Pauli, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777190
- Sponsor's protocol ID
- 00005107
- Status last verified
- Oct 2022
- First submitted
- 17 May 2016
- Last updated
- 13 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Oral Misoprostol and Vaginal Misoprostol for Cervical Ripening and Induction of Labor
- ClinicalTrials.gov ID
- NCT02777190
- Acronym / sponsor ID
- 00005107
- Keywords
- misoprostol, cytotec, cervical ripening, labor, induced, active labor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient research staff to recruit and complete study
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 23 Apr 2019 (actual)
- Study completion
- 23 Apr 2019 (actual)
- First posted
- 19 May 2016 (estimated)
- Results
- Posted 13 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral misoprostol | Experimental | Drug: Misoprostoloral misoprostol given 25 mcg every 2 hours |
| Vaginal misoprostol | Active comparator | Drug: Misoprostolvaginal misoprostol given 25 mcg every 4 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pregnant Female Patients greater than or equal to 18 years of age
- Induction of labor for a single live intrauterine pregnancy
- Greater than or equal to 37 weeks gestational age
- Cephalic presentation
- 20 minute reassuring fetal heart rate (reactive nonstress test (NST))
Key exclusion criteria (8 listed)
- Previous uterine scar
- Contraindication to vaginal delivery
- Patients with preeclampsia
- Grand multiparty - greater than or equal to 5 live births or stillbirths
- Premature rupture of membranes
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 |
|---|---|---|
| MisoprostolAlso: CytotecComparing dosing of misoprostol 25 mcg orally every 2 hours versus 25 mcg vaginally every 4 hours. | Drug | Oral misoprostol, Vaginal misoprostol |
Primary outcome
Time to Active Labor
Time frame: from start of induction of labor (first misoprostol administration) to active phase of labor, up to 3 days.
Active phase of labor defined as greater than or equal to 6 cm cervical dilation
12 secondary outcomes
Time to Initiation 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
Time to Vaginal Delivery
Time frame: from start of induction of labor (first misoprostol administration) to vaginal delivery, up to 3 days
Cesarean Section Rate
Time frame: From enrollment until delivery, up to 3 days
Rate of Tachysystole
Time frame: from enrollment until delivery, up to 3 days
Rate of Tachysystole Causing Non-reassuring Fetal Heart Tones
Time frame: From enrollment until delivery, up to 3 days
Rate of Need for Tocolysis
Time frame: from enrollment until delivery, up to 3 days
Rate of Chorioamnionitis
Time frame: from enrollment until delivery, up to 3 days
Rate of Meconium Stained Fluid
Time frame: from enrollment until delivery, up to 3 days
Neonatal Morbidity
Time frame: 4 hours from delivery
Rate of Anti-emetic Use
Time frame: from enrollment until delivery, up to 3 days
Rate of Vaginal Delivery Within 24 Hours
Time frame: 24 hours from start of induction of labor (first misoprostol administration)
Rate of Abandoning Misoprostol for Cervical Ripening and Switching to Mechanical Dilation for Cervical Ripening
Time frame: from enrollment until delivery, up to 3 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34155622Kerr 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.
- Individual participant dataSharing planned: No
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.
Jaimey Pauli, MD principal investigator
Milton S. Hershey Medical Center
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 Misoprostol in people with Labor; Forced or Induced, Affecting Fetus or Newborn and Pregnancy, run by Milton S. Hershey Medical Center 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 8 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: stopped early, as of the sponsor's last update on 13 Oct 2022. 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 13 Oct 2022). 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?
Time to Active Labor (time frame: from start of induction of labor (first misoprostol administration) to active phase of labor, up to 3 days.). 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 NCT02777190, which also lists 1 linked publication.
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 13 Oct 2022.