Induction of LaborNCT03489798
Comparison of Two Protocols of Misoprostol (PGE1) and the Rate of Cesarean Section Due to Failed Induction.
A study testing 6 misoprostol and 3 misoprostol in people with Induction of Labor, run by Saint Thomas Hospital, Panama at 1 site in Panama.
Trial summary
To compare two protocols of misoprostol use for cervical ripening: 3 doses (25 ug vaginal each) or up to six doses, every six hours, until an adequate cervical condititon was achieved (BIshop score > 6). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Induction of Labor
- What is being tested?
- 6 misoprostol and 3 misoprostol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 sitePanama
- Study dates
- 5 Apr 2018to 15 Sep 2018
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women between 34 and 42 weeks of gestation.
- Obstetric indication for termination of pregnancy.
- No fetal evidence of fetal distress
Who cannot join
- Any contraindication for the use of misoprostol.
- Oligohydramnios.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Protocols of Misoprostol (PGE1) and Their Effect on the Rate of Cesarean Section Due to Failed Induction. A Randomized, Controlled Trial.
To compare two protocols of misoprostol use for cervical ripening: 3 doses (25 ug vaginal each) or up to six doses, every six hours, until an adequate cervical condititon was achieved (BIshop score > 6). In the first group, after 3 doses, the patient was sent to the delivery room for induction with oxytocin and in case of failure, a cesarean section was indicated for this reason. In the second group, up to six doses were used in a similar fashion. Rates of success were evaluated, as well as maternal and fetal complications.
- Conditions
- Induction of Labor
- Being tested
- 6 misoprostol, 3 misoprostol
- Keywords
- Induction of labor, Misoprostol, Failed induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 misoprostolProcedure or surgery
Also called Prostaglandin E1 25 ug dose
Up to 6 doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score > 6.
3 misoprostolProcedure or surgery
Also called Prostaglandin E1 25 ug dose
Up to 3 doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score > 6.
| Study group | Role | What they receive |
|---|---|---|
| 6 Misoprostol | Experimental | Up to six doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score > 6. Receives: Procedure: 6 misoprostol |
| 3 misoprostol | Active comparator | Up to 3 doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score > 6. Receives: Procedure: 3 misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal birth
Number of patients that had a vaginal birth
Measured: 48 hours
Secondary outcomes (2)
Maternal complications
Number of patients that developed a maternal complication due to the use of misoprostol (abruptio placenta, postpartum bleeding, uterine atony).
Measured: 48 hours
Fetal complications
Number of patients that developed a fetal complication due to the use of misoprostol (stillbirth, fetal distress).
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start5 Apr 2018
- Primary completion31 May 2018
- Study completion15 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Thomas Hospital, Panama
- Sponsor type
- University, hospital or other
- Collaborators
- Sistema Nacional de Investigadores de Panamá
- Responsible party
- Principal investigator, Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489798
- Sponsor's protocol ID
- MHST2016-04
- Status last verified
- Oct 2018
- First submitted
- 13 Feb 2018
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Protocols of Misoprostol (PGE1) and Their Effect on the Rate of Cesarean Section Due to Failed Induction. A Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT03489798
- Acronym / sponsor ID
- MHST2016-04
- Conditions
- Induction of Labor
- Keywords
- Induction of labor, Misoprostol, Failed induction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Saint Thomas Hospital, PanamaUniversity, hospital or other
- Collaborators
- Sistema Nacional de Investigadores de Panamá
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 15 Sep 2018 (actual)
- First posted
- 5 Apr 2018 (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.
To compare two protocols of misoprostol use for cervical ripening: 3 doses (25 ug vaginal each) or up to six doses, every six hours, until an adequate cervical condititon was achieved (BIshop score > 6). In the first group, after 3 doses, the patient was sent to the delivery room for induction with oxytocin and in case of failure, a cesarean section was indicated for this reason. In the second group, up to six doses were used in a similar fashion. Rates of success were evaluated, as well as maternal and fetal complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6 Misoprostol | Experimental | Procedure: 6 misoprostolUp to six doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score > 6. |
| 3 misoprostol | Active comparator | Procedure: 3 misoprostolUp to 3 doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score > 6. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women between 34 and 42 weeks of gestation.
- Obstetric indication for termination of pregnancy.
- No fetal evidence of fetal distress
Key exclusion criteria (2 listed)
- Any contraindication for the use of misoprostol.
- Oligohydramnios.
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 |
|---|---|---|
| 6 misoprostolAlso: Prostaglandin E1 25 ug doseUp to 6 doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score > 6. | Procedure or surgery | 6 Misoprostol |
| 3 misoprostolAlso: Prostaglandin E1 25 ug doseUp to 3 doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score > 6. | Procedure or surgery | 3 misoprostol |
Primary outcome
Vaginal birth
Time frame: 48 hours
Number of patients that had a vaginal birth
2 secondary outcomes
Maternal complications
Time frame: 48 hours
Fetal complications
Time frame: 48 hours
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 12 Oct 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 misoprostol and 3 misoprostol in people with Induction of Labor, run by Saint Thomas Hospital, Panama at 1 site in Panama.
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 3 inclusion and 2 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 12 Oct 2018. 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 Panama. 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.
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?
Vaginal birth (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Oct 2018.