Induction of LaborNCT06909721
Misoprostol Versus Dinoprostone in Induction of Labor
A study testing Misoprostol in people with Induction of Labor, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Endogenous prostaglandins, derived from the uterus, cervix, placenta, and membranes of fetus, are essential for cervical ripening ,the investigators aimed to compare Misoprostol and Dinoprostone as regarding to cost-effectiveness and safety in induction of Labor. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Induction of Labor
- 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
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2023to 10 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnancy
- Intact membranes
- Bishop score 4-6 or less
- Women accepted to participate in the study
- Indicated patient of induction 39WeeKs of pregnancy or more
Who cannot join
- Fetal congenital anomalies
- malpresentation
- irregular fetal heart rate patterns
- placental abnormalities, and any contraindications to administering prostaglandins
- involving a history of glaucoma, asthma, cardiovascular disease or preexisting cardiac
- prior uterine operation, cesarean delivery
- maternal chronic illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Misoprostol Versus Dinoprostone in Induction of Labor,Randomized Controlled Study
Endogenous prostaglandins, derived from the uterus, cervix, placenta, and membranes of fetus, are essential for cervical ripening ,the investigators aimed to compare Misoprostol and Dinoprostone as regarding to cost-effectiveness and safety in induction of Labor.
Both misoprostol and dinoprostone have demonstrated efficiently in cervical ripening and labor induction. However, their use must be carefully monitored to minimize risks and optimize outcomes. Factors such as parity, gestational age, maternal medical history, and the indication for induction should be considered when selecting the most appropriate induction method. Additionally, patient preferences and institutional protocols play a role in decision-making.
Recent advancements in IOL techniques include the use of combination methods, like mechanical and pharmacological agents, to enhance efficacy and reduce complications. For example, the combination of a Foley catheter with low-dose misoprostol has been shown to improve cervical ripening and reduce the time to delivery . Additionally, the development of new pharmacological agents, such as misoprostol vaginal inserts and controlled-release dinoprostone gels, offers promising alternatives for safe and effective labor induction.
Read the detailed description
Induction of labor (IOL) is a critical obstetric technique utilized to trigger uterine contractions artificially after fetal viability but prior to the spontaneous onset of labor. It is primarily aimed at achieving cervical effacement and dilatation to facilitate vaginal delivery. This intervention is often necessary in various clinical scenarios, like post-term pregnancies, preeclampsia, gestational diabetes, intrauterine growth restriction, or maternal medical conditions that pose risks to the mother or fetus. Globally, IOL is performed in up to 25% of pregnancies, highlighting its importance in modern obstetrics . In Europe, the rates of IOL vary significantly, ranging from 7% to 33%, reflecting differences in healthcare systems, clinical guidelines, and patient demographics .
The success of IOL is heavily influenced by the condition of cervix at the time of induction. Cervical status is assessed using the Bishop's scoring system, which evaluates factors like cervical dilatation, effacement, consistency, position, and fetal station. A favorable cervix, characterized by a Bishop's score of 6 or higher, is related to an elevated probability of successful vaginal delivery. In contrast, an unfavorable cervix (posterior, firm, and long) presents significant challenges, decreasing the chances of vaginal birth and increasing the risk of cesarean delivery.
Cervical ripening is a fundamental process that prepares the cervix for labor by increasing its softness and distensibility. This process is controlled by a complex interplay of hormonal, biochemical, vasodilatory and inflammatory alterations. Endogenous prostaglandins (PGs), produced by uterus, cervix, fetal membranes and placenta, have a pivotal role in these changes. PGs stimulate the breakdown of collagen fibers, increase water content, and promote the release of cytokines and other inflammatory mediators that facilitate cervical remodeling. When natural ripening is insufficient, iatrogenic methods are employed to induce cervical ripening and labor. These methods include mechanical agents, such as Foley catheters, cervical dilators, or amniotomy, and pharmacological agents, such as prostaglandins, oxytocin, and smooth muscle stimulants like herbs or castor oil.
Despite its widespread use, IOL is not without risks. Common challenges include ineffective labor induction, prolonged labor, and excessive uterine activity, which may result in complications like fetal distress, uterine rupture, and an elevated probability of cesarean delivery. Prostaglandins, which mediate their effects through specific G protein-coupled receptors (GPCRs), are integral to the inflammatory and immune responses that drive cervical ripening .
However, the therapeutic utilization of natural PGs is restricted by their quick metabolism, chemical instability, and short half-life, as well as their propensity to cause side effects like vomiting, diarrhea, nausea, and uterine hyperstimulation .
To overcome these limitations, synthetic prostaglandins have been developed and are widely used in clinical practice. Misoprostol, a synthetic analog of prostaglandin E1 (PGE1), is the most frequently utilized agent due to its stability, cost-effectiveness, and ease of administration. It is available in oral, sublingual, and vaginal forms, making it a versatile option for labor induction. Misoprostol is particularly effective in low-resource settings because of its affordability and stability at room temperature. However, its use requires careful dosing to avoid complications such as uterine hyperstimulation and fetal distress .
Dinoprostone, a synthetic analog of prostaglandin E2 (PGE2), is another widely used agent, particularly in settings where controlled release and fewer side effects are desired. Dinoprostone is available in gel, insert, and suppository forms, allowing for tailored dosing based on individual patient needs. It is often preferred in cases where a slower, more controlled induction process is warranted. However, dinoprostone is more expensive than misoprostol and requires refrigeration, which can limit its use in resource-constrained settings.
- 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 Dinoprostone
to compare Misoprostol and Dinoprostone as regarding to cost-effectiveness and safety in induction of normal Labor
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol Group | Active comparator | About 100 pregnant women received Misoprostol vaginal tablets (25-50 mcg every 6 Hours for 4 doeses and re use after 48 hour) for induction of normal labour Receives: Drug: Misoprostol |
| Dinoprostone Group | Active comparator | About 100 pregnant women received Dinoprostone vaginal tablets (3mg vaginal tablets, one tablet to be inserted high in posterior fornix and the second tablet inserted after 8 hour if labour not established with maximum does 6 mg) for induction of normal labour Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction of Labor
Assessment of labour induction by the using the modified Bishop score . The bishop score evaluated cervical readiness for labor induction by examining five components: cervical consistency, cervical dilation, station of the baby, cervical position, and cervical length. Cervical dilation measured the opening of the cervix on a scale from 0 (no dilation) to 3 (≥5 cm). Cervical consistency assessed the texture of the cervix, scored from 0 (firm) to 2 (soft). Cervical position was rated from 0 (posterior) to 2 (anterior). The baby's station was scored from -3 (high in the pelvis) to +3 (deeply engaged). Cervical length was evaluated on a scale from 0 (≥3 cm) to 2 (<2 cm). These components were combined to produce a total Bishop score varying from 0 to 13.
Measured: 48 hours after drug administration
Induction of Labor
Assessment of labour induction by the using the Apgar score. The Apgar score, performed at one and five minutes after birth, assessed the newborn's condition across five factors: respiratory effort, heart rate, reflex irritability, tone of muscle, and color of skin, with each scored from zero to two. Heart rate was rated as 2 if it exceeded 100 beats per minute, 1 if below 100, and 0 if absent.
Measured: just after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start10 Jun 2023
- Primary completion1 Jun 2024
- Study completion10 Jun 2024
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.
- More trials run by Al-Azhar UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Elkhodary Hassan, Al-Azhar University
- Investigators
- Mahmoud Ebrahim Al Rashidi, Professor, Study chair, Obstetrics and Gynecology Department, Faculty of medicine,Al-Azhar University, Assiut.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909721
- Sponsor's protocol ID
- Shaimaa Elkhodary
- Status last verified
- Jun 2023
- First submitted
- 19 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Misoprostol Versus Dinoprostone in Induction of Labor,Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06909721
- Acronym / sponsor ID
- Shaimaa Elkhodary
- Conditions
- Induction of Labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 3 Apr 2025 (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.
Endogenous prostaglandins, derived from the uterus, cervix, placenta, and membranes of fetus, are essential for cervical ripening ,the investigators aimed to compare Misoprostol and Dinoprostone as regarding to cost-effectiveness and safety in induction of Labor.
Both misoprostol and dinoprostone have demonstrated efficiently in cervical ripening and labor induction. However, their use must be carefully monitored to minimize risks and optimize outcomes. Factors such as parity, gestational age, maternal medical history, and the indication for induction should be considered when selecting the most appropriate induction method. Additionally, patient preferences and institutional protocols play a role in decision-making.
Recent advancements in IOL techniques include the use of combination methods, like mechanical and pharmacological agents, to enhance efficacy and reduce complications. For example, the combination of a Foley catheter with low-dose misoprostol has been shown to improve cervical ripening and reduce the time to delivery . Additionally, the development of new pharmacological agents, such as misoprostol vaginal inserts and controlled-release dinoprostone gels, offers promising alternatives for safe and effective labor induction.
Detailed description
Induction of labor (IOL) is a critical obstetric technique utilized to trigger uterine contractions artificially after fetal viability but prior to the spontaneous onset of labor. It is primarily aimed at achieving cervical effacement and dilatation to facilitate vaginal delivery. This intervention is often necessary in various clinical scenarios, like post-term pregnancies, preeclampsia, gestational diabetes, intrauterine growth restriction, or maternal medical conditions that pose risks to the mother or fetus. Globally, IOL is performed in up to 25% of pregnancies, highlighting its importance in modern obstetrics . In Europe, the rates of IOL vary significantly, ranging from 7% to 33%, reflecting differences in healthcare systems, clinical guidelines, and patient demographics .
The success of IOL is heavily influenced by the condition of cervix at the time of induction. Cervical status is assessed using the Bishop's scoring system, which evaluates factors like cervical dilatation, effacement, consistency, position, and fetal station. A favorable cervix, characterized by a Bishop's score of 6 or higher, is related to an elevated probability of successful vaginal delivery. In contrast, an unfavorable cervix (posterior, firm, and long) presents significant challenges, decreasing the chances of vaginal birth and increasing the risk of cesarean delivery.
Cervical ripening is a fundamental process that prepares the cervix for labor by increasing its softness and distensibility. This process is controlled by a complex interplay of hormonal, biochemical, vasodilatory and inflammatory alterations. Endogenous prostaglandins (PGs), produced by uterus, cervix, fetal membranes and placenta, have a pivotal role in these changes. PGs stimulate the breakdown of collagen fibers, increase water content, and promote the release of cytokines and other inflammatory mediators that facilitate cervical remodeling. When natural ripening is insufficient, iatrogenic methods are employed to induce cervical ripening and labor. These methods include mechanical agents, such as Foley catheters, cervical dilators, or amniotomy, and pharmacological agents, such as prostaglandins, oxytocin, and smooth muscle stimulants like herbs or castor oil.
Despite its widespread use, IOL is not without risks. Common challenges include ineffective labor induction, prolonged labor, and excessive uterine activity, which may result in complications like fetal distress, uterine rupture, and an elevated probability of cesarean delivery. Prostaglandins, which mediate their effects through specific G protein-coupled receptors (GPCRs), are integral to the inflammatory and immune responses that drive cervical ripening .
However, the therapeutic utilization of natural PGs is restricted by their quick metabolism, chemical instability, and short half-life, as well as their propensity to cause side effects like vomiting, diarrhea, nausea, and uterine hyperstimulation .
To overcome these limitations, synthetic prostaglandins have been developed and are widely used in clinical practice. Misoprostol, a synthetic analog of prostaglandin E1 (PGE1), is the most frequently utilized agent due to its stability, cost-effectiveness, and ease of administration. It is available in oral, sublingual, and vaginal forms, making it a versatile option for labor induction. Misoprostol is particularly effective in low-resource settings because of its affordability and stability at room temperature. However, its use requires careful dosing to avoid complications such as uterine hyperstimulation and fetal distress .
Dinoprostone, a synthetic analog of prostaglandin E2 (PGE2), is another widely used agent, particularly in settings where controlled release and fewer side effects are desired. Dinoprostone is available in gel, insert, and suppository forms, allowing for tailored dosing based on individual patient needs. It is often preferred in cases where a slower, more controlled induction process is warranted. However, dinoprostone is more expensive than misoprostol and requires refrigeration, which can limit its use in resource-constrained settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol Group | Active comparator | Drug: MisoprostolAbout 100 pregnant women received Misoprostol vaginal tablets (25-50 mcg every 6 Hours for 4 doeses and re use after 48 hour) for induction of normal labour |
| Dinoprostone Group | Active comparator | Drug: MisoprostolAbout 100 pregnant women received Dinoprostone vaginal tablets (3mg vaginal tablets, one tablet to be inserted high in posterior fornix and the second tablet inserted after 8 hour if labour not established with maximum does 6 mg) for induction of normal labour |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Singleton pregnancy
- Intact membranes
- Bishop score 4-6 or less
- Women accepted to participate in the study
- Indicated patient of induction 39WeeKs of pregnancy or more
Key exclusion criteria (7 listed)
- Fetal congenital anomalies
- malpresentation
- irregular fetal heart rate patterns
- placental abnormalities, and any contraindications to administering prostaglandins
- involving a history of glaucoma, asthma, cardiovascular disease or preexisting cardiac
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: Dinoprostoneto compare Misoprostol and Dinoprostone as regarding to cost-effectiveness and safety in induction of normal Labor | Drug | Dinoprostone Group, Misoprostol Group |
Primary outcome
Induction of Labor
Time frame: 48 hours after drug administration
Assessment of labour induction by the using the modified Bishop score . The bishop score evaluated cervical readiness for labor induction by examining five components: cervical consistency, cervical dilation, station of the baby, cervical position, and cervical length. Cervical dilation measured the opening of the cervix on a scale from 0 (no dilation) to 3 (≥5 cm). Cervical consistency assessed the texture of the cervix, scored from 0 (firm) to 2 (soft). Cervical position was rated from 0 (posterior) to 2 (anterior). The baby's station was scored from -3 (high in the pelvis) to +3 (deeply engaged). Cervical length was evaluated on a scale from 0 (≥3 cm) to 2 (<2 cm). These components were combined to produce a total Bishop score varying from 0 to 13.
Induction of Labor
Time frame: just after delivery
Assessment of labour induction by the using the Apgar score. The Apgar score, performed at one and five minutes after birth, assessed the newborn's condition across five factors: respiratory effort, heart rate, reflex irritability, tone of muscle, and color of skin, with each scored from zero to two. Heart rate was rated as 2 if it exceeded 100 beats per minute, 1 if below 100, and 0 if absent.
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 3 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Induction of Labor
Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingPhase 3
Preeclampsia Intervention Netherlands
Pre-Eclampsia Onset Less Than 37 Weeks, Pre-Eclampsia
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Not yet recruiting
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety
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.
Mahmoud Ebrahim Al Rashidi, Professor study chair
Obstetrics and Gynecology Department, Faculty of medicine,Al-Azhar University, Assiut.
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 in people with Induction of Labor, run by Al-Azhar University at 1 site in Egypt.
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 7 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 3 Apr 2025. 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 Egypt. 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?
Induction of Labor (time frame: 48 hours after drug administration). 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 3 Apr 2025.