Labor PainPhase 3NCT02758340
Failure of Vaginal Delivery After Induction
A Phase 3 study testing Misoprostol and foley's balloon catheter in people with Labor Pain, run by Karachi Medical and Dental College at 1 site in Pakistan.
Trial summary
The study will compare the number of women who deliver vaginally after artificial initiation of labor pains(i.e. induction of labor) by two methods. Half of the women would receive tablet misoprostol vaginally and the other half would receive tablet misoprostol and foley's balloon catheter both. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Misoprostol and foley's balloon catheter
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 335 participants
- Where
- 1 sitePakistan
- Study dates
- Apr 2016to Nov 2016
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gestational age > 37 weeks assessed by Last Menstrual Period and dating scan.
- Women with singleton pregnancy assessed by ultrasound.
- Fetus in vertex presentation assessed by ultrasound.
- Age 20-40 years.
- Bishop score <4.
Who cannot join
- Non-consenting.
- Gestational age < 37 weeks.
- Patients with history of placenta previa.
- Patients with history of placental abruption.
- Ruptured membranes.
- Patients with history of vaginal infection.
- Patients with history of congenital anomalies in previous deliveries.
- Patients with history of stroke, renal impairment and chronic obstructive pulmonary disease, chronic liver disease and congestive cardiac failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Maternal Outcome Between Patients Undergoing Induction of Labor With Oral Misoprostol Alone and Oral Misoprostol and Foley's Catheter Both at a Tertiary Care Hospital
The study will compare the number of women who deliver vaginally after artificial initiation of labor pains(i.e. induction of labor) by two methods. Half of the women would receive tablet misoprostol vaginally and the other half would receive tablet misoprostol and foley's balloon catheter both.
Read the detailed description
Artificial initiation of labor pains has become a common occurrence. A variety of methods are employed to initiate labor pains. Labor pains are more successful in culminating into vaginal delivery if the neck of womb that is the cervix is soft (ripe). This is usually achieved by ripening agents. They include drugs and devices that help soften the cervix. Misoprostol and foley's balloon catheter both are used to soften the cervix so that vaginal delivery is possible. Both work on different aspects of the softening of cervix.
Misoprostol acts on shortening the cervix and making it more pliable Foley's balloon helps to open up the cervix that is it aids in dilating the cervical canal.
- Conditions
- Labor Pain
- Being tested
- Misoprostol, foley's balloon catheter
- Keywords
- induction of labor, misoprostol, foley's balloon catheter
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called cytotec
Women would be given misoprostol tablet by mouth
foley's balloon catheterDevice
Also called foley's catheter
foley's balloon catheter would be inserted through vagina into cervix.
| Study group | Role | What they receive |
|---|---|---|
| M=misoprostol | Experimental | Patients who would receive Only oral misoprostol{(50 micrograms) tab cytotec ¼ tablets (Searle)}. All patients in this group will be given oral misoprostol 50 μg per dose. The dose will be repeated at 4 hours interval up to a maximum of 4 doses till labor is induced (3 contractions per 10 minutes). If labor is not established within 4 hours of the administration of the fourth dose, induction will be considered to be failed Receives: Drug: Misoprostol |
| M+F=MISOPROSTOL+FOLEY'S BALLOON CATHETER | Experimental | All patients in this group will be explained the technique of foley's catheter ballooning and informed consent will be taken. The cervix will be visualized with the help of Cusco's speculum. The balloon will be inflated with about 30 cc of sterile water. The catheter will be pulled down to bring the balloon into the cervical canal and will be tapped around the thigh. Patients will also be given oral misoprostol 50 μg per dose. The dose will be repeated at 4 hours interval up to a maximum of 4 doses till labor is induced (3 contractions per 10 minutes). Receives: Drug: Misoprostol; Device: foley's balloon catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
failure of vaginal delivery i.e.percentage of women in both groups who would fail to deliver vaginally after 24 hours of induction.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startApr 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karachi Medical and Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, samia husain, Karachi Medical and Dental College
- Investigators
- samia husain, MBBS, Principal investigator, Karachi Medical and Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758340
- Sponsor's protocol ID
- KarachiDMC
- Status last verified
- Nov 2016
- First submitted
- 27 Apr 2016
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
PubMed 36996264
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Maternal Outcome Between Patients Undergoing Induction of Labor With Oral Misoprostol Alone and Oral Misoprostol and Foley's Catheter Both at a Tertiary Care Hospital
- ClinicalTrials.gov ID
- NCT02758340
- Acronym / sponsor ID
- KarachiDMC
- Conditions
- Labor Pain
- Keywords
- induction of labor, misoprostol, foley's balloon catheter
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Karachi Medical and Dental CollegeUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 2 May 2016 (estimated)
- 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.
The study will compare the number of women who deliver vaginally after artificial initiation of labor pains(i.e. induction of labor) by two methods. Half of the women would receive tablet misoprostol vaginally and the other half would receive tablet misoprostol and foley's balloon catheter both.
Detailed description
Artificial initiation of labor pains has become a common occurrence. A variety of methods are employed to initiate labor pains. Labor pains are more successful in culminating into vaginal delivery if the neck of womb that is the cervix is soft (ripe). This is usually achieved by ripening agents. They include drugs and devices that help soften the cervix. Misoprostol and foley's balloon catheter both are used to soften the cervix so that vaginal delivery is possible. Both work on different aspects of the softening of cervix.
Misoprostol acts on shortening the cervix and making it more pliable Foley's balloon helps to open up the cervix that is it aids in dilating the cervical canal.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M=misoprostol | Experimental | Drug: MisoprostolPatients who would receive Only oral misoprostol{(50 micrograms) tab cytotec ¼ tablets (Searle)}. All patients in this group will be given oral misoprostol 50 μg per dose. The dose will be repeated at 4 hours interval up to a maximum of 4 doses till labor is induced (3 contractions per 10 minutes). If labor is not established within 4 hours of the administration of the fourth dose, induction will be considered to be failed |
| M+F=MISOPROSTOL+FOLEY'S BALLOON CATHETER | Experimental | Drug: Misoprostol, Device: foley's balloon catheterAll patients in this group will be explained the technique of foley's catheter ballooning and informed consent will be taken. The cervix will be visualized with the help of Cusco's speculum. The balloon will be inflated with about 30 cc of sterile water. The catheter will be pulled down to bring the balloon into the cervical canal and will be tapped around the thigh. Patients will also be given oral misoprostol 50 μg per dose. The dose will be repeated at 4 hours interval up to a maximum of 4 doses till labor is induced (3 contractions per 10 minutes). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Gestational age > 37 weeks assessed by Last Menstrual Period and dating scan.
- Women with singleton pregnancy assessed by ultrasound.
- Fetus in vertex presentation assessed by ultrasound.
- Age 20-40 years.
- Bishop score <4.
Key exclusion criteria (8 listed)
- Non-consenting.
- Gestational age < 37 weeks.
- Patients with history of placenta previa.
- Patients with history of placental abruption.
- Ruptured membranes.
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: cytotecWomen would be given misoprostol tablet by mouth | Drug | M+F=MISOPROSTOL+FOLEY'S BALLOON CATHETER, M=misoprostol |
| foley's balloon catheterAlso: foley's catheterfoley's balloon catheter would be inserted through vagina into cervix. | Device | M+F=MISOPROSTOL+FOLEY'S BALLOON CATHETER |
Primary outcome
failure of vaginal delivery i.e.percentage of women in both groups who would fail to deliver vaginally after 24 hours of induction.
Time frame: six months
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 29 Nov 2016.
- Derived from this study: PubMed 36996264de 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. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
- Individual participant dataSharing planned: No
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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.
samia husain, MBBS principal investigator
Karachi Medical and Dental College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Misoprostol and foley's balloon catheter in people with Labor Pain, run by Karachi Medical and Dental College 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 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: finished, as of the sponsor's last update on 29 Nov 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
failure of vaginal delivery i.e.percentage of women in both groups who would fail to deliver vaginally after 24 hours of induction. (time frame: six months). 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 NCT02758340, which also lists 1 linked publication.
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 29 Nov 2016.