Cervical RipeningNCT07685756
Cervical Ripening Balloon Compared With Vaginal Misoprostol for Cervical Ripening in Obese Woman at Term
A study testing Cervical folleys and Misoprostol in people with Cervical Ripening, run by HUDDA Ahmad at 1 site in Pakistan.
Trial summary
Cervical ripening balloon compared with vaginal misoprostol for cervical ripening in obese woman at term Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cervical Ripening
- What is being tested?
- Cervical folleys and Misoprostol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2026to 1 Jun 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
- obese women bmi >30, Bishop score <6 at time of ripening Singleton pregnancy Gestational age more than 37 weeks
Who cannot join
- pregnancy with fetal demise congenital anomalies, History of uterine surgery In active labour >4 cm dialated Obs complication History of uterine hyper stimulation and uterine rupture Feel malpresentation
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan institute of medical sciences Islamabad
Islamabad, Punjab Province, 46604
About this study
Cervical ripening balloon compared with vaginal misoprostol for cervical ripening in obese woman at term
- Conditions
- Cervical Ripening
- Being tested
- Cervical folleys, Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical folleysDevice
We will compare effectiveness of cervical ripening with cervical folleys compared to misoprostol in obese women at term
MisoprostolDrug
We will compare effectiveness of ripening with misoprostol comoared with cervical folleys in obese women at term
| Study group | Role | What they receive |
|---|---|---|
| Experimental group having cervical ripening with cervical folleys | Experimental | We will study effectiveness of ripening with cervical folleys compared to misoprostol Receives: Device: Cervical folleys |
| Experimental group having cervical ripening with misoprostol | Active comparator | We will compare effectiveness of ripening with misoprostol with cervical folleys Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Less rate of instrumental delivery and c section
Less rate of instrumental delivery and c section in ripening of obese women with cervical folleys as compared to misoprostol at term
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 May 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RipeningStudies 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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HUDDA Ahmad
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, HUDDA Ahmad, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685756
- Sponsor's protocol ID
- PIMS hospital islamabad
- Status last verified
- May 2026
- First submitted
- 29 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Ripening Balloon Compared With Vaginal Misoprostol for Cervical Ripening in Obese Woman at Term
- ClinicalTrials.gov ID
- NCT07685756
- Acronym / sponsor ID
- PIMS hospital islamabad
- Conditions
- Cervical Ripening
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- HUDDA AhmadOther government
- Study start
- 1 May 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 6 Jul 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.
Cervical ripening balloon compared with vaginal misoprostol for cervical ripening in obese woman at term
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group having cervical ripening with cervical folleys | Experimental | Device: Cervical folleysWe will study effectiveness of ripening with cervical folleys compared to misoprostol |
| Experimental group having cervical ripening with misoprostol | Active comparator | Drug: MisoprostolWe will compare effectiveness of ripening with misoprostol with cervical folleys |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- obese women bmi >30, Bishop score <6 at time of ripening Singleton pregnancy Gestational age more than 37 weeks
Key exclusion criteria (1 listed)
- pregnancy with fetal demise congenital anomalies, History of uterine surgery In active labour >4 cm dialated Obs complication History of uterine hyper stimulation and uterine rupture Feel malpresentation
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 |
|---|---|---|
| Cervical folleysWe will compare effectiveness of cervical ripening with cervical folleys compared to misoprostol in obese women at term | Device | Experimental group having cervical ripening with cervical folleys |
| MisoprostolWe will compare effectiveness of ripening with misoprostol comoared with cervical folleys in obese women at term | Drug | Experimental group having cervical ripening with misoprostol |
Primary outcome
Less rate of instrumental delivery and c section
Time frame: 12 months
Less rate of instrumental delivery and c section in ripening of obese women with cervical folleys as compared to misoprostol at term
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 6 Jul 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.
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 Cervical folleys and Misoprostol in people with Cervical Ripening, run by HUDDA Ahmad 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: under way, not looking for participants, as of the sponsor's last update on 6 Jul 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?
Less rate of instrumental delivery and c section (time frame: 12 months). 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 6 Jul 2026.