Labor, InducedNCT07559812
Comparison of Vaginal PGE2 (Dinoprostone) and Vaginal Misoprostol for Induction of Labour in Primigravid Term Pregnancy
A study testing Misoprostol and Dinoprostone 3 mg in people with Labor, Induced and Term Pregnancy, run by Mayo Hospital Lahore at 1 site in Pakistan.
Trial summary
This randomized controlled trial was conducted to compare vaginal misoprostol and vaginal PGE2 (dinoprostone) for induction of labour in primigravid women with term pregnancy. Labour induction is commonly required when pregnancy reaches term but spontaneous labour has not started. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Labor, Induced, Term Pregnancy, Cervical Ripening
- What is being tested?
- Misoprostol and Dinoprostone 3 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 sitePakistan
- Study dates
- 29 Oct 2025to 29 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women age 18-45 years, primigravida, undergoing induction of labour at Gestational age ≥ 40 weeks by last menstrual period (LMP)
- Not having spontaneous labor at 40 weeks of gestation by last menstrual period (LMP)
Who cannot join
- Absent fetal cardiac activity on CTG
- Non-reassuring CTG on admission
- Anomalous fetus on ante-natal ultrasound record.
- Not willing to participate.
Trial locations and contacts
1 site in 1 country.
About this study
This randomized controlled trial was conducted to compare vaginal misoprostol and vaginal PGE2 (dinoprostone) for induction of labour in primigravid women with term pregnancy. Labour induction is commonly required when pregnancy reaches term but spontaneous labour has not started. Different medicines are used to soften the cervix and start uterine contractions, but their effectiveness may vary. A total of 240 primigravid women with singleton pregnancy at 40 weeks or more of gestation, who were not in spontaneous labour and were planned for induction of labour, were included. Participants were allocated into two equal groups. Women in Group M received a 50 μg vaginal misoprostol insert, while women in Group D received a 3 mg vaginal dinoprostone insert. Both medicines were given under aseptic conditions in the inpatient obstetrics setting. The main purpose of the study was to compare the proportion of women who achieved successful vaginal delivery after induction. The study also assessed the time interval from first treatment to vaginal delivery among successful cases. Additional maternal and neonatal outcomes included peripartum hemorrhage, premature rupture of membranes, and admission of the newborn to the neonatal intensive care unit within 48 hours after delivery.
- Conditions
- Labor, Induced, Term Pregnancy, Cervical Ripening
- Being tested
- Misoprostol, Dinoprostone 3 mg
- Keywords
- Induction of labor, Vaginal misoprostol, Vaginal dinoprostone, Primigravid women, Term pregnancy, Vaginal delivery, Cervical ripening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
50 μg misoprostol was administered as a vaginal insert for induction of labour in primigravid women with term pregnancy.
Dinoprostone 3 mgDrug
3 mg dinoprostone was administered as a vaginal insert for induction of labour in primigravid women with term pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Group M Misoprostol | Experimental | Participants in this group received 50 μg vaginal misoprostol insert under aseptic conditions for induction of labour. Receives: Drug: Misoprostol |
| Group D Dinoprostone | Active comparator | Participants in this group received 3 mg vaginal dinoprostone insert under aseptic conditions for induction of labour Receives: Drug: Dinoprostone 3 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Vaginal Delivery
Successful vaginal delivery was assessed as the proportion of participants who achieved vaginal delivery after induction of labour with the assigned study drug.
Measured: From first administration of the assigned vaginal insert until vaginal delivery, assessed up to 48 hours after first treatment administration.
Secondary outcomes (3)
Time Interval From First Treatment to Vaginal Delivery
The time interval from administration of the assigned vaginal insert to vaginal delivery was measured in hours among participants who achieved successful vaginal delivery.
Measured: From first administration of the assigned vaginal insert until vaginal delivery, assessed up to 48 hours after first treatment administration.
Peripartum Hemorrhage
Peripartum hemorrhage was recorded as Yes when excessive blood loss was associated with both blood transfusion during or within 3 days after delivery and a fall in hemoglobin of ≥2 g/dL from baseline. Baseline hemoglobin was measured at admission to the labour room and post-delivery hemoglobin was assessed 48 hours after delivery.
Measured: From delivery until 3 days after delivery.
Neonatal Intensive Care Unit Admission
Neonatal intensive care unit admission was assessed as the proportion of newborns admitted to the neonatal intensive care unit after delivery.
Measured: Within 48 hours after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start29 Oct 2025
- Primary completion29 Apr 2026 (estimated)
- Study completion29 Apr 2026 (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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Hospital Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adeel Ahmed, Mayo Hospital Lahore
- Investigators
- Saher Anam, Principal investigator, Mayo Hospital Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559812
- Sponsor's protocol ID
- Mayo5
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 30 Apr 2026
- 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 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Vaginal PGE2 (Dinoprostone) and Vaginal Misoprostol for Induction of Labour in Primigravid Term Pregnancy
- ClinicalTrials.gov ID
- NCT07559812
- Acronym / sponsor ID
- Mayo5
- Conditions
- Labor, Induced, Term Pregnancy, Cervical Ripening
- Keywords
- Induction of labor, Vaginal misoprostol, Vaginal dinoprostone, Primigravid women, Term pregnancy, Vaginal delivery, Cervical ripening
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Mayo Hospital LahoreUniversity, hospital or other
- Study start
- 29 Oct 2025 (actual)
- Primary completion
- 29 Apr 2026 (estimated)
- Study completion
- 29 Apr 2026 (estimated)
- First posted
- 30 Apr 2026 (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.
This randomized controlled trial was conducted to compare vaginal misoprostol and vaginal PGE2 (dinoprostone) for induction of labour in primigravid women with term pregnancy. Labour induction is commonly required when pregnancy reaches term but spontaneous labour has not started. Different medicines are used to soften the cervix and start uterine contractions, but their effectiveness may vary. A total of 240 primigravid women with singleton pregnancy at 40 weeks or more of gestation, who were not in spontaneous labour and were planned for induction of labour, were included. Participants were allocated into two equal groups. Women in Group M received a 50 μg vaginal misoprostol insert, while women in Group D received a 3 mg vaginal dinoprostone insert. Both medicines were given under aseptic conditions in the inpatient obstetrics setting. The main purpose of the study was to compare the proportion of women who achieved successful vaginal delivery after induction. The study also assessed the time interval from first treatment to vaginal delivery among successful cases. Additional maternal and neonatal outcomes included peripartum hemorrhage, premature rupture of membranes, and admission of the newborn to the neonatal intensive care unit within 48 hours after delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group M Misoprostol | Experimental | Drug: MisoprostolParticipants in this group received 50 μg vaginal misoprostol insert under aseptic conditions for induction of labour. |
| Group D Dinoprostone | Active comparator | Drug: Dinoprostone 3 mgParticipants in this group received 3 mg vaginal dinoprostone insert under aseptic conditions for induction of labour |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women age 18-45 years, primigravida, undergoing induction of labour at Gestational age ≥ 40 weeks by last menstrual period (LMP)
- Not having spontaneous labor at 40 weeks of gestation by last menstrual period (LMP)
Key exclusion criteria (4 listed)
- Absent fetal cardiac activity on CTG
- Non-reassuring CTG on admission
- Anomalous fetus on ante-natal ultrasound record.
- Not willing to participate.
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 |
|---|---|---|
| Misoprostol50 μg misoprostol was administered as a vaginal insert for induction of labour in primigravid women with term pregnancy. | Drug | Group M Misoprostol |
| Dinoprostone 3 mg3 mg dinoprostone was administered as a vaginal insert for induction of labour in primigravid women with term pregnancy. | Drug | Group D Dinoprostone |
Primary outcome
Successful Vaginal Delivery
Time frame: From first administration of the assigned vaginal insert until vaginal delivery, assessed up to 48 hours after first treatment administration.
Successful vaginal delivery was assessed as the proportion of participants who achieved vaginal delivery after induction of labour with the assigned study drug.
3 secondary outcomes
Time Interval From First Treatment to Vaginal Delivery
Time frame: From first administration of the assigned vaginal insert until vaginal delivery, assessed up to 48 hours after first treatment administration.
Peripartum Hemorrhage
Time frame: From delivery until 3 days after delivery.
Neonatal Intensive Care Unit Admission
Time frame: Within 48 hours after delivery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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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.
Saher Anam principal investigator
Mayo Hospital Lahore
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 and Dinoprostone 3 mg in people with Labor, Induced and Term Pregnancy, run by Mayo Hospital Lahore at 1 site in Pakistan.
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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Successful Vaginal Delivery (time frame: From first administration of the assigned vaginal insert until vaginal delivery, assessed up to 48 hours after first treatment administration.). 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 30 Apr 2026.