Induction of LaborEarly Phase 1BEGINNCT03976037

Buccal Versus Vaginal Misoprostol In Combination With Foley Bulb

A Early Phase 1 study testing Misoprostol in people with Induction of Labor, run by Christiana Care Health Services at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Combined misoprostol and Foley bulb catheter has been shown to be an effective induction method. However, optimal route of administration for misoprostol has not been established. Read more about this study

Who is it for?: Ages 18 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for: Induction of Labor
What is being tested?: Misoprostol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 216 participants
Where: 1 siteUnited States
Study dates: 4 Jun 2019to 1 Feb 2021
Phase: Early Phase 1
Are there results?: None posted in the registry

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 to 55 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

≥18 years of age
full term (≥37 weeks) gestations determined by routine obstetrical guidelines
singleton gestation in cephalic presentation
Both nulliparous and multiparous women
Intact membranes
Cervical dilation ≤2cm

Who cannot join

Any contraindication to a vaginal delivery or to misoprostol
fetal demise
Multifetal gestation
prior uterine surgery, previous cesarean section
Tachysystole was defined as at least 6 contractions in 10 minutes for 2 consecutive 10-minute periods
women with HIV, and women with medical conditions requiring an assisted second stage
Additional exclusion criteria were as follows: category 3 fetal heart rate tracing, hemolysis elevated liver enzymes and low platelets (HELLP) syndrome or eclampsia, growth restriction <10th percentile (based on Hadlock growth curves) with reversal of flow in umbilical artery Doppler studies, and growth restriction <5th percentile with elevated, absent, or reversal of flow in umbilical artery Doppler studies
As described in previous research (Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016;128(6):1357-1364)

Trial locations and contacts

1 site in 1 country.

United States1 site

Christiana Care Health Systems
Newark, Delaware, 19713

Other trials in United States

About this study

Official title: Buccal Versus Vaginal Misoprostol In Combination With Foley Bulb for Labor Induction at Term: a Randomized Controlled Trial

Combined misoprostol and Foley bulb catheter has been shown to be an effective induction method. However, optimal route of administration for misoprostol has not been established.

Therefore, the purpose of this study is to compare the effectiveness and safety of combination buccal miso-foley to combination vaginal miso-foley for third trimester cervical ripening and induction of labor.

Read the detailed description

This randomized controlled trial of consenting women undergoing induction of labor with combined misoprostol and Foley catheter seeks to efficacy of vaginal versus buccal misoprostol route of administration.

This project will include 216 women presenting at Christiana Care Health System. Women will be included if they are at least 37 weeks gestation, have a singleton pregnancy, have intact membranes and are undergoing an induction of labor using a Foley catheter combined with misoprostol. Following admission, women will be randomized into either vaginal or buccal misoprostol.

Women will be randomized with equal probability to the intervention group using block randomization stratified by party.

Patients will receive 25 micrograms of misoprostol along with the insertion of a16F Foley catheter. Misoprostol can be repeated up to five additional times for a maximum of 24 hours or a total of 6 doses if the patient is not contracting more than 3 times per 10 minutes. The remainder of labor management will be at the discretion of each woman's obstetric provider.

Prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review

Conditions: Induction of Labor
Being tested: Misoprostol

What participants receive

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

MisoprostolDrug
Also called cytotec
Women randomized to either vaginal or buccal misoprostol-cervical Foley group will have both misoprostol and a cervical Foley placed. Patients will receive 25 micrograms of vaginal or buccal misoprostol along with the insertion of a16F Foley catheter with stylet. The Foley balloon catheter will be filled with 30cc balloon inserted digitally or by direct visualization with a speculum. The Foley bulb will be placed just above the level of the internal os and inflated with 30cc of sterile water.
vaginal or Buccal misoprostol can be repeated up to five additional times for a maximum of 24 hours or a total of 6 doses if the patient is not contracting more than 3 times per 10 minutes. If the patient is contracting more than 3 times per 10 minutes after 6 hours, oxytocin protocol is initiated.

Study groups in NCT03976037
Study group	Role	What they receive
Vaginal Misoprostol in combination with foley bulb	Active comparator	Women in the vaginal misoprostol-cervical Foley group will have both misoprostol and a cervical Foley placed. Patients will receive 25 micrograms of misoprostol per vagina along with the insertion of a16F Foley catheter with a stylet. The Foley balloon catheter will be filled with 30cc balloon inserted digitally or by direct visualization with a speculum. The Foley bulb will be placed just above the level of the internal os and inflated with 30cc of sterile water. Vaginal misoprostol can be repeated up to five additional times for a maximum of 24 hours or a total of 6 doses if the patient is not contracting more than 3 times per 10 minutes. If the patient is contracting more than 3 times per 10 minutes after 6 hours, oxytocin protocol is initiated. Receives: Drug: Misoprostol
Buccal Misoprostol in combination with foley bulb	Active comparator	misoprostol and a cervical Foley placed. Patients will receive 25 micrograms of buccal misoprostol along with the insertion of a16F Foley catheter with stylet. The Foley balloon catheter will be filled with 30cc balloon inserted digitally or by direct visualization with a speculum. The Foley bulb will be placed just above the level of the internal os and inflated with 30cc of sterile water. Buccal misoprostol can be repeated up to five additional times for a maximum of 24 hours or a total of 6 doses if the patient is not contracting more than 3 times per 10 minutes. If the patient is contracting more than 3 times per 10 minutes after 6 hours, oxytocin protocol is initiated. Receives: Drug: Misoprostol

What is being measured

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

time to delivery (hours) defined
as time from initiation of induction method to delivery time, regardless of mode of delivery.
Measured: through study completion, an average of 2 year

Secondary outcomes (25)

Rate of Cesarean delivery
yes/no
Measured: through study completion, an average of 2 year
Time to active labor
s time from initiation of induction method to dilatation ≥6cm
Measured: through study completion, an average of 2 year
Maternal length of stay
defined as length of time from admission for induction to discharge postpartum, days
Measured: through study completion, an average of 2 year
Indication for cesarean delivery
The reason for induction: NRFHT, arrest of dilation, arrest of descent, failed IOL, other
Measured: through study completion, an average of 2 year
Rate of 3rd/4th degree perineal laceration
yes/no
Measured: through study completion, an average of 2 year
Rate of Maternal Blood transfusion
yes/no
Measured: through study completion, an average of 2 year
Rate of Endometritis
yes/no; fundal tenderness and fever that required treatment with antibiotics
Measured: through study completion, an average of 2 year
Rate of Wound separation-infection
the need for additional wound closure or the need for antibiotics
Measured: From time of delivery to time of hospital discharge; up to 6 weeks
Rate of Venous thromboembolism
yes/no
Measured: through study completion, an average of 2 year
Rate of Hysterectomy
yes/no
Measured: through study completion, an average of 2 year
Rate of Intensive care unit admission
yes/no
Measured: through study completion, an average of 2 year
Rate of Maternal Death
yes/no
Measured: through study completion, an average of 2 year
Rate of Chorioamnionitis
the presence of maternal fever ≥100·4°f in the presence of maternal or fetal tachycardia or fundal tenderness
Measured: through study completion, an average of 2 year
Rate of terbutaline use
yes/no
Measured: through study completion, an average of 2 year
Rate of Intrauterine pressure catheter use
yes/no
Measured: through study completion, an average of 2 year
Rate of Amnioinfusion
yes/no
Measured: through study completion, an average of 2 year
Rate of Analgesia use
yes/no
Measured: through study completion, an average of 2 year
Rate of Severe respiratory distress syndrome
defined as intubation and mechanical ventilation for a minimum of 12 hours
Measured: From time of delivery to hospital discharge; up to 6 weeks
Rate of Culture proven-presumed neonatal sepsis
yes/no
Measured: From time of delivery to hospital discharge; up to 6 weeks
Rate of Neonatal blood transfusion
yes/no
Measured: From time of delivery to hospital discharge; up to 6 weeks
Rate of Hypoxic ischemic encephalopathy
yes/no
Measured: From time of delivery to hospital discharge; up to 6 weeks
Rate of Intraventricular hemorrhage grade 3 or 4
yes/no
Measured: From time of delivery to hospital discharge; up to 6 weeks
Rate of Necrotizing enterocolitis
yes/no
Measured: From time of delivery to hospital discharge; up to 6 weeks
Rate of head cooling.
yes/no
Measured: From time of delivery to hospital discharge; up to 6 weeks
Rate of NICU admission
yes/no
Measured: From time of delivery to hospital discharge; up to 6 weeks

Timeline

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

4 Jun 20191 Feb 2021

First posted5 Jun 2019
Study start4 Jun 2019
Primary completion20 Jan 2020
Study completion1 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Induction of LaborStudies 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: Early Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 216 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03976037
Sponsor's protocol ID: DDD# 604291
Acronym: BEGIN
Status last verified: Feb 2021
First submitted: 31 May 2019
Last updated: 26 Feb 2021
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1357-1364. doi: 10.1097/AOG.0000000000001778.
PubMed 27824758
Chung JH, Huang WH, Rumney PJ, Garite TJ, Nageotte MP. A prospective randomized controlled trial that compared misoprostol, Foley catheter, and combination misoprostol-Foley catheter for labor induction. Am J Obstet Gynecol. 2003 Oct;189(4):1031-5. doi: 10.1067/s0002-9378(03)00842-1.
PubMed 14586350
Gomez HB, Hoffman MK, Caplan R, Ruhstaller K, Young MHH, Sciscione AC. Buccal vs vaginal misoprostol combined with Foley catheter for cervical ripening at term (the BEGIN trial): a randomized controlled trial. Am J Obstet Gynecol. 2021 May;224(5):524.e1-524.e8. doi: 10.1016/j.ajog.2021.02.016. Epub 2021 Feb 19.
PubMed 33617796

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
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Not yet recruiting
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All Induction of Labor trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Buccal Versus Vaginal Misoprostol In Combination With Foley Bulb for Labor Induction at Term: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03976037
Acronym / sponsor ID: BEGIN / DDD# 604291
Conditions: Induction of Labor
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 216 participants (actual)
Lead sponsor: Christiana Care Health ServicesUniversity, hospital or other
Study start: 4 Jun 2019 (actual)
Primary completion: 20 Jan 2020 (actual)
Study completion: 1 Feb 2021 (actual)
First posted: 5 Jun 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Combined misoprostol and Foley bulb catheter has been shown to be an effective induction method. However, optimal route of administration for misoprostol has not been established.

Detailed description

Women will be randomized with equal probability to the intervention group using block randomization stratified by party.

Prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Vaginal Misoprostol in combination with foley bulb	Active comparator	Drug: MisoprostolWomen in the vaginal misoprostol-cervical Foley group will have both misoprostol and a cervical Foley placed. Patients will receive 25 micrograms of misoprostol per vagina along with the insertion of a16F Foley catheter with a stylet. The Foley balloon catheter will be filled with 30cc balloon inserted digitally or by direct visualization with a speculum. The Foley bulb will be placed just above the level of the internal os and inflated with 30cc of sterile water. Vaginal misoprostol can be repeated up to five additional times for a maximum of 24 hours or a total of 6 doses if the patient is not contracting more than 3 times per 10 minutes. If the patient is contracting more than 3 times per 10 minutes after 6 hours, oxytocin protocol is initiated.
Buccal Misoprostol in combination with foley bulb	Active comparator	Drug: Misoprostolmisoprostol and a cervical Foley placed. Patients will receive 25 micrograms of buccal misoprostol along with the insertion of a16F Foley catheter with stylet. The Foley balloon catheter will be filled with 30cc balloon inserted digitally or by direct visualization with a speculum. The Foley bulb will be placed just above the level of the internal os and inflated with 30cc of sterile water. Buccal misoprostol can be repeated up to five additional times for a maximum of 24 hours or a total of 6 doses if the patient is not contracting more than 3 times per 10 minutes. If the patient is contracting more than 3 times per 10 minutes after 6 hours, oxytocin protocol is initiated.

Who may qualify

Ages: 18 to 55 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

≥18 years of age
full term (≥37 weeks) gestations determined by routine obstetrical guidelines
singleton gestation in cephalic presentation
Both nulliparous and multiparous women
Intact membranes

Key exclusion criteria (8 listed)

Any contraindication to a vaginal delivery or to misoprostol
fetal demise
Multifetal gestation
prior uterine surgery, previous cesarean section
Tachysystole was defined as at least 6 contractions in 10 minutes for 2 consecutive 10-minute periods

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: cytotecWomen randomized to either vaginal or buccal misoprostol-cervical Foley group will have both misoprostol and a cervical Foley placed. Patients will receive 25 micrograms of vaginal or buccal misoprostol along with the insertion of a16F Foley catheter with stylet. The Foley balloon catheter will be filled with 30cc balloon inserted digitally or by direct visualization with a speculum. The Foley bulb will be placed just above the level of the internal os and inflated with 30cc of sterile water. vaginal or Buccal misoprostol can be repeated up to five additional times for a maximum of 24 hours or a total of 6 doses if the patient is not contracting more than 3 times per 10 minutes. If the patient is contracting more than 3 times per 10 minutes after 6 hours, oxytocin protocol is initiated.	Drug	Buccal Misoprostol in combination with foley bulb, Vaginal Misoprostol in combination with foley bulb

Primary outcome

time to delivery (hours) defined
Time frame: through study completion, an average of 2 year
as time from initiation of induction method to delivery time, regardless of mode of delivery.

25 secondary outcomes

Rate of Cesarean delivery
Time frame: through study completion, an average of 2 year
Time to active labor
Time frame: through study completion, an average of 2 year
Maternal length of stay
Time frame: through study completion, an average of 2 year
Indication for cesarean delivery
Time frame: through study completion, an average of 2 year
Rate of 3rd/4th degree perineal laceration
Time frame: through study completion, an average of 2 year
Rate of Maternal Blood transfusion
Time frame: through study completion, an average of 2 year
Rate of Endometritis
Time frame: through study completion, an average of 2 year
Rate of Wound separation-infection
Time frame: From time of delivery to time of hospital discharge; up to 6 weeks
Rate of Venous thromboembolism
Time frame: through study completion, an average of 2 year
Rate of Hysterectomy
Time frame: through study completion, an average of 2 year
Rate of Intensive care unit admission
Time frame: through study completion, an average of 2 year
Rate of Maternal Death
Time frame: through study completion, an average of 2 year
Rate of Chorioamnionitis
Time frame: through study completion, an average of 2 year
Rate of terbutaline use
Time frame: through study completion, an average of 2 year
Rate of Intrauterine pressure catheter use
Time frame: through study completion, an average of 2 year
Rate of Amnioinfusion
Time frame: through study completion, an average of 2 year
Rate of Analgesia use
Time frame: through study completion, an average of 2 year
Rate of Severe respiratory distress syndrome
Time frame: From time of delivery to hospital discharge; up to 6 weeks
Rate of Culture proven-presumed neonatal sepsis
Time frame: From time of delivery to hospital discharge; up to 6 weeks
Rate of Neonatal blood transfusion
Time frame: From time of delivery to hospital discharge; up to 6 weeks
Rate of Hypoxic ischemic encephalopathy
Time frame: From time of delivery to hospital discharge; up to 6 weeks
Rate of Intraventricular hemorrhage grade 3 or 4
Time frame: From time of delivery to hospital discharge; up to 6 weeks
Rate of Necrotizing enterocolitis
Time frame: From time of delivery to hospital discharge; up to 6 weeks
Rate of head cooling.
Time frame: From time of delivery to hospital discharge; up to 6 weeks
Rate of NICU admission
Time frame: From time of delivery to hospital discharge; up to 6 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
Background: PubMed 27824758Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1357-1364. doi: 10.1097/AOG.0000000000001778.
Background: PubMed 14586350Chung JH, Huang WH, Rumney PJ, Garite TJ, Nageotte MP. A prospective randomized controlled trial that compared misoprostol, Foley catheter, and combination misoprostol-Foley catheter for labor induction. Am J Obstet Gynecol. 2003 Oct;189(4):1031-5. doi: 10.1067/s0002-9378(03)00842-1.
Derived from this study: PubMed 33617796Gomez HB, Hoffman MK, Caplan R, Ruhstaller K, Young MHH, Sciscione AC. Buccal vs vaginal misoprostol combined with Foley catheter for cervical ripening at term (the BEGIN trial): a randomized controlled trial. Am J Obstet Gynecol. 2021 May;224(5):524.e1-524.e8. doi: 10.1016/j.ajog.2021.02.016. Epub 2021 Feb 19.
Individual participant dataSharing planned: No

Related trials for Induction of Labor

Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
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Preeclampsia Intervention Netherlands
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A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
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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.

Helen B Gomez, MD principal investigator

Christiana Care Health Services

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Misoprostol in people with Induction of Labor, run by Christiana Care Health Services 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 6 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: finished, as of the sponsor's last update on 26 Feb 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 delivery (hours) defined (time frame: through study completion, an average of 2 year). 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 NCT03976037, which also lists 3 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 Feb 2021.