Induced; BirthNCT07821099
Outcome of Concurrent Versus Sequential Method of Induction of Labour in Term Pregnancy
A study testing Foley Catheter and PGE2 Vaginal Pessary in people with Induced; Birth, run by Khyber Medical University Peshawar at 1 site in Pakistan.
Trial summary
This randomized controlled trial will compare two methods of induction of labour in women with term pregnancy: concurrent use of a Foley catheter and PGE2 vaginal pessary versus sequential use of the two methods. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Induced; Birth
- What is being tested?
- Foley Catheter and PGE2 Vaginal Pessary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 sitePakistan
- Study dates
- 14 Sep 2026to 20 Mar 2027
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women aged 18-40 years with a singleton cephalic fetus between 37 and 42 weeks of gestation who require induction of labour, with BMI 20-35 kg/m², intact membranes, and reassuring cardiotocography (CTG), will be included.
Who cannot join
- Women with meconium-stained liquor, antepartum haemorrhage, low-lying placenta defined as placental edge less than 2 cm from the internal os on ultrasonography, pre-eclampsia, fetal growth restriction, previously scarred uterus, estimated fetal weight greater than 4 kg on ultrasound, cephalopelvic disproportion, or liquor abnormalities will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Lady Reading Hospital
Peshawar, KPK, 25000
Shezadi Saima Hussain, MHR, +92 333 7111981, saima.hussain@lrh.edu.pk
Dr Jawad Khan, PhD, +92 334 9011681, mdrjawad@yahoo.com
About this study
Official title: Outcome of Concurrent Versus Sequential Method of Induction of Labour in Term Pregnancy: A Randomized Controlled Trial
This randomized controlled trial will compare two methods of induction of labour in women with term pregnancy: concurrent use of a Foley catheter and PGE2 vaginal pessary versus sequential use of the two methods. The study will assess whether using both methods concurrently is more effective and safe than using them sequentially. The primary focus is the rate of vaginal delivery within 24 hours after initiation of induction. Participants will be women with term pregnancy (37-42 weeks) admitted for induction of labour without significant comorbidities.
Read the detailed description
Induction of labour is commonly performed when continuation of pregnancy is considered less beneficial than delivery. This randomized controlled trial will compare the effectiveness and safety of two approaches to cervical ripening and induction of labour in women with term pregnancy.
Eligible participants will have a gestational age of 37-42 weeks and will be admitted to the hospital for induction of labour without significant comorbidities. Gestational age will be confirmed using a dating scan or last menstrual period, and baseline fetal monitoring will be performed using cardiotocography (CTG) before induction.
Participants will be randomly allocated to one of two treatment groups.
In the concurrent group, a PGE2 vaginal pessary and a Foley catheter will be inserted concurrently. The Foley catheter balloon will be inflated with 30 mL of normal saline.
In the sequential group, the Foley catheter will be inserted first, followed by insertion of the PGE2 vaginal pessary 12 hours later.
The study will primarily assess the rate of vaginal delivery within 24 hours of initiation of induction. The study will also assess the overall effectiveness and safety of the two induction approaches, including the induction-to-delivery interval and relevant maternal and fetal complications.
Potential complications associated with induction of labour include failure of induction, uterine hyperstimulation, fetal distress or abnormal CTG, meconium-stained liquor, postpartum haemorrhage, uterine rupture, and chorioamnionitis. Participants will be continuously monitored during the induction process so that appropriate clinical management can be provided if complications occur.
The findings of this study may contribute to the development of safe, effective, and patient-centred induction-of-labour protocols, particularly in resource-constrained healthcare settings.
- Conditions
- Induced; Birth
- Being tested
- Foley Catheter, PGE2 Vaginal Pessary
- Keywords
- Vaginal delivery, Sequential induction, Cervical ripening, Induction of labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foley CatheterDevice
A Foley catheter will be used for mechanical cervical ripening. The balloon will be inflated with 30 mL of normal saline.
PGE2 Vaginal PessaryDrug
A PGE2 vaginal pessary will be used as a pharmacological method of cervical ripening during induction of labour.
| Study group | Role | What they receive |
|---|---|---|
| Concurrent Induction of Labour | Experimental | Participants will receive concurrent cervical ripening with a PGE2 vaginal pessary and insertion of a Foley catheter. The Foley catheter balloon will be inflated with 30 mL of normal saline. Both interventions will be initiated concurrently at the start of induction of labour. Receives: Device: Foley Catheter; Drug: PGE2 Vaginal Pessary |
| Sequential Induction of Labour | Active comparator | Participants will receive sequential cervical ripening with a Foley catheter followed by insertion of a PGE2 vaginal pessary 12 hours later. The Foley catheter will be inserted first, followed by the PGE2 vaginal pessary after 12 hours. Receives: Device: Foley Catheter; Drug: PGE2 Vaginal Pessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from initiation of induction of labour to vaginal delivery
Time interval from the initiation of cervical ripening intervention to vaginal delivery, measured in hours.
Measured: From initiation of induction of labour until vaginal delivery, up to 24 hours
Successful vaginal delivery
Proportion of participants who achieve vaginal delivery following induction of labour.
Measured: From initiation of induction of labour until delivery, up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start14 Sep 2026 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion20 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Induced; BirthStudies 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
- Participants will be randomly allocated to one of two parallel intervention groups: concurrent induction using Foley catheter plus PGE2 vaginal pessary, or sequential induction using Foley catheter followed by PGE2 vaginal pessary 12 hours later.
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khyber Medical University Peshawar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shahzadi Saima Hussain, MHR, Principal investigator, Khyber Medical University Peshawar, PakistanDr Jawad Khan, PhD, Study director, Khyber Medical University Peshawar, PakistanDr Mehnaz Faisal, MHPE, FCPS, Principal investigator, Lady Reading Hospital Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821099
- Sponsor's protocol ID
- KMU/DIR/CTU/2026/12
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan is in place to share individual participant data with other researchers.
Publications
de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2019 Oct 18;10(10):CD001233. doi: 10.1002/14651858.CD001233.pub3.
PubMed 31623014Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD001233. doi: 10.1002/14651858.CD001233.pub2.
PubMed 22419277Carbone JF, Tuuli MG, Fogertey PJ, Roehl KA, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial. Obstet Gynecol. 2013 Feb;121(2 Pt 1):247-252. doi: 10.1097/AOG.0b013e31827e5dca.
PubMed 23303106Eser A, Ozkaya E, Abide CY, Eser T, Eser GY, Abike F, Tayyar AT, Eroglu M. Transcervical Foley balloon catheter and vaginal prostaglandin E2 insert combination vs. vaginal prostaglandin E2 insert only for induction of labor at term: a randomized clinical trial. Arch Gynecol Obstet. 2019 Feb;299(2):451-457. doi: 10.1007/s00404-018-4998-8. Epub 2018 Dec 7.
PubMed 30536117
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Concurrent Versus Sequential Method of Induction of Labour in Term Pregnancy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07821099
- Acronym / sponsor ID
- KMU/DIR/CTU/2026/12
- Conditions
- Induced; Birth
- Keywords
- Vaginal delivery, Sequential induction, Cervical ripening, Induction of labor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Khyber Medical University PeshawarUniversity, hospital or other
- Study start
- 14 Sep 2026 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 20 Mar 2027 (estimated)
- First posted
- 15 Sep 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 will compare two methods of induction of labour in women with term pregnancy: concurrent use of a Foley catheter and PGE2 vaginal pessary versus sequential use of the two methods. The study will assess whether using both methods concurrently is more effective and safe than using them sequentially. The primary focus is the rate of vaginal delivery within 24 hours after initiation of induction. Participants will be women with term pregnancy (37-42 weeks) admitted for induction of labour without significant comorbidities.
Detailed description
Induction of labour is commonly performed when continuation of pregnancy is considered less beneficial than delivery. This randomized controlled trial will compare the effectiveness and safety of two approaches to cervical ripening and induction of labour in women with term pregnancy.
Eligible participants will have a gestational age of 37-42 weeks and will be admitted to the hospital for induction of labour without significant comorbidities. Gestational age will be confirmed using a dating scan or last menstrual period, and baseline fetal monitoring will be performed using cardiotocography (CTG) before induction.
Participants will be randomly allocated to one of two treatment groups.
In the concurrent group, a PGE2 vaginal pessary and a Foley catheter will be inserted concurrently. The Foley catheter balloon will be inflated with 30 mL of normal saline.
In the sequential group, the Foley catheter will be inserted first, followed by insertion of the PGE2 vaginal pessary 12 hours later.
The study will primarily assess the rate of vaginal delivery within 24 hours of initiation of induction. The study will also assess the overall effectiveness and safety of the two induction approaches, including the induction-to-delivery interval and relevant maternal and fetal complications.
Potential complications associated with induction of labour include failure of induction, uterine hyperstimulation, fetal distress or abnormal CTG, meconium-stained liquor, postpartum haemorrhage, uterine rupture, and chorioamnionitis. Participants will be continuously monitored during the induction process so that appropriate clinical management can be provided if complications occur.
The findings of this study may contribute to the development of safe, effective, and patient-centred induction-of-labour protocols, particularly in resource-constrained healthcare settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated to one of two parallel intervention groups: concurrent induction using Foley catheter plus PGE2 vaginal pessary, or sequential induction using Foley catheter followed by PGE2 vaginal pessary 12 hours later.
| Arm | Type | Receives |
|---|---|---|
| Concurrent Induction of Labour | Experimental | Device: Foley Catheter, Drug: PGE2 Vaginal PessaryParticipants will receive concurrent cervical ripening with a PGE2 vaginal pessary and insertion of a Foley catheter. The Foley catheter balloon will be inflated with 30 mL of normal saline. Both interventions will be initiated concurrently at the start of induction of labour. |
| Sequential Induction of Labour | Active comparator | Device: Foley Catheter, Drug: PGE2 Vaginal PessaryParticipants will receive sequential cervical ripening with a Foley catheter followed by insertion of a PGE2 vaginal pessary 12 hours later. The Foley catheter will be inserted first, followed by the PGE2 vaginal pessary after 12 hours. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women aged 18-40 years with a singleton cephalic fetus between 37 and 42 weeks of gestation who require induction of labour, with BMI 20-35 kg/m², intact membranes, and reassuring cardiotocography (CTG), will be included.
Key exclusion criteria (1 listed)
- Women with meconium-stained liquor, antepartum haemorrhage, low-lying placenta defined as placental edge less than 2 cm from the internal os on ultrasonography, pre-eclampsia, fetal growth restriction, previously scarred uterus, estimated fetal weight greater than 4 kg on ultrasound, cephalopelvic disproportion, or liquor abnormalities will be excluded.
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 |
|---|---|---|
| Foley CatheterA Foley catheter will be used for mechanical cervical ripening. The balloon will be inflated with 30 mL of normal saline. | Device | Concurrent Induction of Labour, Sequential Induction of Labour |
| PGE2 Vaginal PessaryA PGE2 vaginal pessary will be used as a pharmacological method of cervical ripening during induction of labour. | Drug | Concurrent Induction of Labour, Sequential Induction of Labour |
Primary outcome
Time from initiation of induction of labour to vaginal delivery
Time frame: From initiation of induction of labour until vaginal delivery, up to 24 hours
Time interval from the initiation of cervical ripening intervention to vaginal delivery, measured in hours.
Successful vaginal delivery
Time frame: From initiation of induction of labour until delivery, up to 24 hours
Proportion of participants who achieve vaginal delivery following induction of labour.
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 15 Sep 2026.
- Background: PubMed 31623014de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2019 Oct 18;10(10):CD001233. doi: 10.1002/14651858.CD001233.pub3.
- Background: PubMed 22419277Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD001233. doi: 10.1002/14651858.CD001233.pub2.
- Background: PubMed 23303106Carbone JF, Tuuli MG, Fogertey PJ, Roehl KA, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial. Obstet Gynecol. 2013 Feb;121(2 Pt 1):247-252. doi: 10.1097/AOG.0b013e31827e5dca.
- Background: PubMed 30536117Eser A, Ozkaya E, Abide CY, Eser T, Eser GY, Abike F, Tayyar AT, Eroglu M. Transcervical Foley balloon catheter and vaginal prostaglandin E2 insert combination vs. vaginal prostaglandin E2 insert only for induction of labor at term: a randomized clinical trial. Arch Gynecol Obstet. 2019 Feb;299(2):451-457. doi: 10.1007/s00404-018-4998-8. Epub 2018 Dec 7.
- Individual participant dataSharing planned: No. No plan is in place to share individual participant data with other researchers.
Related trials for Induced; Birth
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
Active, not recruiting
MR-guided Focused Ultrasound Plus GCase
Parkinsons Disease
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
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.
Shahzadi Saima Hussain, MHR principal investigator
Khyber Medical University Peshawar, Pakistan
Dr Jawad Khan, PhD study director
Khyber Medical University Peshawar, Pakistan
Dr Mehnaz Faisal, MHPE, FCPS principal investigator
Lady Reading Hospital Peshawar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foley Catheter and PGE2 Vaginal Pessary in people with Induced; Birth, run by Khyber Medical University Peshawar 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 15 Sep 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?
Contact Shahzadi Saima Hussain, MHR (+923337111981, saima.hussain@lrh.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from initiation of induction of labour to vaginal delivery (time frame: From initiation of induction of labour until vaginal delivery, up to 24 hours). 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?
On the ClinicalTrials.gov record for NCT07821099, which also lists 4 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 15 Sep 2026.