Labor, InducedNCT05857059
Misoprostol for Induction of Labor in Obese Women: Comparison Between 25 and 50 mcg Oral Administration
A study testing Misoprostol 25 mcg and Misoprostol 50 mcg in people with Labor, Induced and Obesity, run by Unidade Local de Saúde de Coimbra, EPE at 1 site in Portugal.
Trial summary
In recent decades, obesity has become a prevalent issue in Portugal, with 38.6% and 13.8% of the population being overweight or obese, respectively. Obese pregnant women have a higher rate of obstetric complications, including hypertensive complications, gestational diabetes and fetal macrosomia, leading to increased… Read more about this study
- Who is it for?
- Ages 15 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor, Induced, Obesity, Pregnancy
- What is being tested?
- Misoprostol 25 mcg and Misoprostol 50 mcg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 sitePortugal
- Study dates
- 15 Oct 2019to 30 Jun 2024
- 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 15 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- BMI ≥ 30 kg/m2 recorded based on maternal weight at preconception or in the first trimester
- Singleton live gestation with vertex presentation
- Pregnancies followed in our institution with sonographic confirmation of gestational age in the first trimester
- Obstetrical indication for labor induction
- Bishop score of <5 at the time of induction of labor
Who cannot join
- Underweight and normal weight women (BMI <30 kg/m2)
- Known hypersensitivity to prostaglandins
- Preterm gestations (< 37 weeks)
- Multiple gestation
- Women who cannot give their informed consent
- Contraindications for vaginal delivery
- Previous c-section or uterine scar due to previous gynecological surgery
- Maternal or fetal pathology (for example: fetal indications: non-reassuring fetal status - intra-uterine growth restriction with abnormal umbilical doppler, abnormal fetal cardiac rhythm; stillbirth; or maternal/pregnancy related indications such as placenta previa)
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Iolanda João Mora Cruz de Freitas Ferreira
Coimbra, 3000-157
Iolanda Ferreira, 10862@chuc.min-saude.pt
About this study
Official title: Misoprostol for Induction of Labor in Obese Women: Comparison Between 25 and 50 mcg Oral Administration - a Randomized Trial
In recent decades, obesity has become a prevalent issue in Portugal, with 38.6% and 13.8% of the population being overweight or obese, respectively. Obese pregnant women have a higher rate of obstetric complications, including hypertensive complications, gestational diabetes and fetal macrosomia, leading to increased induction of labor (IOL) and cesarean section (CS) rates. To determine the effect of increasing oral misoprostol dose on CS rate in obese pregnant women undergoing IOL, a randomized controlled trial with a sample size of 114 cases in each group was calculated to detect a 15% difference in CS rate. The primary objective is to determine the effect of increasing oral misoprostol dose, with secondary goals being to compare successful IOL rates and their relationship with oral misoprostol dose, as well as to evaluate tolerability and side effects in relation to different doses of oral misoprostol.
Read the detailed description
The prevalence of obesity has increased dramatically in recent decades, with implications for women of reproductive age and changes in obstetric and perinatal outcomes. In Portugal, it is estimated that 38.6 per cent and 13.8 per cent of the population are overweight or obese, respectively. Compared with women of normal weight, obese pregnant women have a higher rate of obstetric complications. These include hypertensive complications, gestational diabetes and fetal macrosomia. These factors lead to an increased need for IOL before the end of the pregnancy and, consequently, to a reduced degree of cervical dilatation prior to IOL. In addition, the above-mentioned co-morbidities are associated with a higher rate of CS. For all these reasons, obese women have higher IOL and CS rates. The literature also confirms that the degree of obesity is directly related to IOL failure. In some studies, the rate of failed induction is 20.2% and 24.2% in women with obesity grades I and II, respectively. However, few studies have been conducted to determine which IOL agents most commonly induce vaginal labour in obese women, and no studies have defined the most appropriate dose for maternal BMI.
This study provides a breakthrough in understanding the mechanism of labour and response to misoprostol in obese women, as there is a lack of prospective human studies in this area.
Sample size calculation was based on CS rate in obese versus non-obese groups as the primary outcome. According to previous studies, a 22% CS rate in non-obese pregnant women undergoing IOL was calculated, with a between-groups difference of 15% on CS rates being considered clinically significant. Therefore, we set the power at 80%, the alpha error at 0.05 and the ratio of the two study groups at 1:1. Accordingly, 114 cases were needed in each group to detect 15% difference in CS rate.
Primary objective: To determine the effect of increasing oral misoprostol dose on CS rate in obese pregnant women undergoing IOL.
Secondary goals: Comparison of successful IOL rates and their relationship with oral misoprostol dose. Evaluation of tolerability and side effects in relation to different doses of oral misoprostol.
- Conditions
- Labor, Induced, Obesity, Pregnancy, Cesarean Section
- Being tested
- Misoprostol 25 mcg, Misoprostol 50 mcg
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol 25 mcgDrug
Misoprostol 50 mcg every 2 hours
Misoprostol 50 mcgDrug
Misoprostol 50 mcg every 2 hours
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol 25 mcg | Active comparator | Participants received misoprostol 25 mcg every 2 hours until the active stage of labour was attained or failed induction was diagnosed Receives: Drug: Misoprostol 25 mcg |
| Misoprostol 50 mcg | Experimental | Participants received misoprostol 25 mcg matching misoprostol 50 mcg every 2 hours until the active stage of labour was attained or failed induction was diagnosed Receives: Drug: Misoprostol 50 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean section rates
Calculation in percentage. An average of 22% cesarean section rate in non-obese pregnant women undergoing IOL was determined, with a between-groups difference of 15% on cesarean section rates being considered clinically significant.
Measured: Up to 3 days after first misoprostol intake until delivery (vaginal or cesarean section)
Indication for cesarean section
The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine guidelines for caesarean section indications are used. When a caesarean section is performed, it will be classified in mutually exclusive categories. These are:
First stage labor dystocia: Yes/No Second stage labor dystocia: Yes/No Abnormal or indeterminate fetal heart rate tracing: Yes/No Failed induction: Yes/No
Measured: Delivery
Secondary outcomes (5)
Rate of vaginal delivery within 24 hours
Percentage of eutocic or instrumental deliveries that occured within a 24h of the first misoprostol intake
Measured: Time of first misoprostol intake until vaginal delivery
Time interval from the first dose of misoprostol to vaginal delivery
Median time in hours
Measured: Time of first misoprostol intake until vaginal delivery
Rate of instrumental delivery
Percentage of vaginal deliveries that need instrumentation with ventouse or forceps
Measured: Delivery
Time interval from the first dose of misoprostol to cesarean section delivery
Median time in hours
Measured: Time of first misoprostol intake until cesarean section delivery
Incidence of misoprostol adverse effects
Tachysystole (defined as at least six uterine contractions in 10 minutes for two consecutive 10-minute periods) and hyperstimulation (defined as the presence of tachysystole or a prolonged uterine contraction lasting 2 or more minutes associated with fetal heart rate abnormalities) will be evaluated
Measured: Time of first misoprostol intake until vaginal or cesarean section delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start15 Oct 2019
- Primary completion31 May 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor, InducedStudies 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
- Model description
- Pregnant women seen at the obstetric clinic of Maternidade Daniel de Matos, with a first trimester ultrasound pregnancy dating at our institution; with a maternal BMI measurement in the first trimester ≥ 30 kg/m2 and with a maternal or obstetric indication for IOL, who agreed to participate in the study. They will be randomized into two groups: one will consist of pregnant women undergoing the basic IOL protocol of Maternidade Daniel de Matos (oral misoprostol 25µcg every 2 hours); the other will be submitted to a 50µcg dosage every 2 hours, maximum of 7 doses per day (maximum 2 days). The pregnant woman will have a choice of an envelope, which will be her group assignment and will be coded until the end of the trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unidade Local de Saúde de Coimbra, EPE
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iolanda Ferreira, Unidade Local de Saúde de Coimbra, EPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857059
- Sponsor's protocol ID
- CHUC-151-17
- Status last verified
- Oct 2023
- First submitted
- 6 Apr 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Misoprostol for Induction of Labor in Obese Women: Comparison Between 25 and 50 mcg Oral Administration - a Randomized Trial
- ClinicalTrials.gov ID
- NCT05857059
- Acronym / sponsor ID
- CHUC-151-17
- Conditions
- Labor, Induced, Obesity, Pregnancy, Cesarean Section
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Unidade Local de Saúde de Coimbra, EPEUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 12 May 2023 (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.
In recent decades, obesity has become a prevalent issue in Portugal, with 38.6% and 13.8% of the population being overweight or obese, respectively. Obese pregnant women have a higher rate of obstetric complications, including hypertensive complications, gestational diabetes and fetal macrosomia, leading to increased induction of labor (IOL) and cesarean section (CS) rates. To determine the effect of increasing oral misoprostol dose on CS rate in obese pregnant women undergoing IOL, a randomized controlled trial with a sample size of 114 cases in each group was calculated to detect a 15% difference in CS rate. The primary objective is to determine the effect of increasing oral misoprostol dose, with secondary goals being to compare successful IOL rates and their relationship with oral misoprostol dose, as well as to evaluate tolerability and side effects in relation to different doses of oral misoprostol.
Detailed description
The prevalence of obesity has increased dramatically in recent decades, with implications for women of reproductive age and changes in obstetric and perinatal outcomes. In Portugal, it is estimated that 38.6 per cent and 13.8 per cent of the population are overweight or obese, respectively. Compared with women of normal weight, obese pregnant women have a higher rate of obstetric complications. These include hypertensive complications, gestational diabetes and fetal macrosomia. These factors lead to an increased need for IOL before the end of the pregnancy and, consequently, to a reduced degree of cervical dilatation prior to IOL. In addition, the above-mentioned co-morbidities are associated with a higher rate of CS. For all these reasons, obese women have higher IOL and CS rates. The literature also confirms that the degree of obesity is directly related to IOL failure. In some studies, the rate of failed induction is 20.2% and 24.2% in women with obesity grades I and II, respectively. However, few studies have been conducted to determine which IOL agents most commonly induce vaginal labour in obese women, and no studies have defined the most appropriate dose for maternal BMI.
This study provides a breakthrough in understanding the mechanism of labour and response to misoprostol in obese women, as there is a lack of prospective human studies in this area.
Sample size calculation was based on CS rate in obese versus non-obese groups as the primary outcome. According to previous studies, a 22% CS rate in non-obese pregnant women undergoing IOL was calculated, with a between-groups difference of 15% on CS rates being considered clinically significant. Therefore, we set the power at 80%, the alpha error at 0.05 and the ratio of the two study groups at 1:1. Accordingly, 114 cases were needed in each group to detect 15% difference in CS rate.
Primary objective: To determine the effect of increasing oral misoprostol dose on CS rate in obese pregnant women undergoing IOL.
Secondary goals: Comparison of successful IOL rates and their relationship with oral misoprostol dose. Evaluation of tolerability and side effects in relation to different doses of oral misoprostol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Pregnant women seen at the obstetric clinic of Maternidade Daniel de Matos, with a first trimester ultrasound pregnancy dating at our institution; with a maternal BMI measurement in the first trimester ≥ 30 kg/m2 and with a maternal or obstetric indication for IOL, who agreed to participate in the study. They will be randomized into two groups: one will consist of pregnant women undergoing the basic IOL protocol of Maternidade Daniel de Matos (oral misoprostol 25µcg every 2 hours); the other will be submitted to a 50µcg dosage every 2 hours, maximum of 7 doses per day (maximum 2 days). The pregnant woman will have a choice of an envelope, which will be her group assignment and will be coded until the end of the trial.
| Arm | Type | Receives |
|---|---|---|
| Misoprostol 25 mcg | Active comparator | Drug: Misoprostol 25 mcgParticipants received misoprostol 25 mcg every 2 hours until the active stage of labour was attained or failed induction was diagnosed |
| Misoprostol 50 mcg | Experimental | Drug: Misoprostol 50 mcgParticipants received misoprostol 25 mcg matching misoprostol 50 mcg every 2 hours until the active stage of labour was attained or failed induction was diagnosed |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- BMI ≥ 30 kg/m2 recorded based on maternal weight at preconception or in the first trimester
- Singleton live gestation with vertex presentation
- Pregnancies followed in our institution with sonographic confirmation of gestational age in the first trimester
- Obstetrical indication for labor induction
- Bishop score of <5 at the time of induction of labor
Key exclusion criteria (8 listed)
- Underweight and normal weight women (BMI <30 kg/m2)
- Known hypersensitivity to prostaglandins
- Preterm gestations (< 37 weeks)
- Multiple gestation
- Women who cannot give their informed consent
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 |
|---|---|---|
| Misoprostol 25 mcgMisoprostol 50 mcg every 2 hours | Drug | Misoprostol 25 mcg |
| Misoprostol 50 mcgMisoprostol 50 mcg every 2 hours | Drug | Misoprostol 50 mcg |
Primary outcome
Cesarean section rates
Time frame: Up to 3 days after first misoprostol intake until delivery (vaginal or cesarean section)
Calculation in percentage. An average of 22% cesarean section rate in non-obese pregnant women undergoing IOL was determined, with a between-groups difference of 15% on cesarean section rates being considered clinically significant.
Indication for cesarean section
Time frame: Delivery
The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine guidelines for caesarean section indications are used. When a caesarean section is performed, it will be classified in mutually exclusive categories. These are: First stage labor dystocia: Yes/No Second stage labor dystocia: Yes/No Abnormal or indeterminate fetal heart rate tracing: Yes/No Failed induction: Yes/No
5 secondary outcomes
Rate of vaginal delivery within 24 hours
Time frame: Time of first misoprostol intake until vaginal delivery
Time interval from the first dose of misoprostol to vaginal delivery
Time frame: Time of first misoprostol intake until vaginal delivery
Rate of instrumental delivery
Time frame: Delivery
Time interval from the first dose of misoprostol to cesarean section delivery
Time frame: Time of first misoprostol intake until cesarean section delivery
Incidence of misoprostol adverse effects
Time frame: Time of first misoprostol intake until vaginal or cesarean section delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol 25 mcg and Misoprostol 50 mcg in people with Labor, Induced and Obesity, run by Unidade Local de Saúde de Coimbra, EPE at 1 site in Portugal.
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 5 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: status not confirmed, as of the sponsor's last update on 24 Oct 2023. 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 Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iolanda Ferreira (+351 239 403 060, 10862@chuc.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cesarean section rates (time frame: Up to 3 days after first misoprostol intake until delivery (vaginal or cesarean section)). The study lists 2 primary outcomes in all. 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 24 Oct 2023.