Cervical Ripening and Induction of LaborNCT02574338
Cervical Ripening: A Comparison Between Intravaginal Misoprostol Tablet and Intracervical Foley's Catheter and Subsequent Induction of Labor, Safety and Efficacy in Federal Teaching Hospital Abakaliki, Ebonyi State, Nigeria.
A study testing Foley's Catheter and prostaglandin E1 analogue in people with Cervical Ripening and Induction of Labor, run by Nwali Matthew Igwe at 1 site in Nigeria.
Trial summary
The aim of this study is to compare the effectiveness and safety of Foley's catheter and misoprostol in cervical ripening. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Ripening and Induction of Labor
- What is being tested?
- Foley's Catheter and prostaglandin E1 analogue
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteNigeria
- Study dates
- Sep 2015to Aug 2018
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parturients who gave consent
- has low bishop score (≤5)
- term singleton cephalic presenting fetus
- intact membranes
- no contraindication to vaginal delivery
Who cannot join
- those who refused consent
- preterm delivery
- vaginal infection
- non-cephalic presentation
- multiple gestation
- low lying placenta/previa,
Show all 9Show fewer
- vaginal bleeding,
- previous cesarean section
- rupture of membranes
Trial locations and contacts
1 site in 1 country.
Nigeria1 site
Federal Teaching Hospital, Abakaliki
Abakaliki, Ebonyi State, 480001
About this study
The aim of this study is to compare the effectiveness and safety of Foley's catheter and misoprostol in cervical ripening.
Read the detailed description
This is a randomized clinical study which will be made up of two arms or groups. The first arm or group - 1 will have cervical ripening with intracervical extraamniotic Foley's catheter while group - 2 will have cervical ripening with intravaginal misoprostol. The parturients will be randomly selected by simple lottery and recruited into the two arms of the study. Each parturient will pick by simple lucky dip from a pool of folded papers with inscription group 1 or group 2 in a bag in a double blinded manner and will be recruited into the group picked among the two arms of the study. The Bishop's score of the cervix will be accurately determined and documented before cervical ripening. Bishop's score of ≥6 will be considered ripe. Oxytocin will be used for induction or augmentation of labor as required.
- Conditions
- Cervical Ripening and Induction of Labor
- Being tested
- Foley's Catheter, prostaglandin E1 analogue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foley's CatheterDevice
intracervical extraamniotic Foley's catheter
prostaglandin E1 analogueDrug
Also called Misoprostol
intravaginal misoprostol
| Study group | Role | What they receive |
|---|---|---|
| group - 1 Foley's Catheter | Active comparator | will have cervical ripening with intracervical extraamniotic Foley's catheter for 24 hours Receives: Device: Foley's Catheter |
| Group - 2 Prostaglandin E1 Analogue | Active comparator | will have cervical ripening with intravaginal misoprostol inserted into the posterior fornix every six hours to a maximum of four doses (24 hours) Receives: Drug: prostaglandin E1 analogue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bishop Score of 6 or more
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2018
- Study completionAug 2018
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 Cervical Ripening and Induction of LaborStudies 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
- Participant, Investigator
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nwali Matthew Igwe
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Nwali Matthew Igwe, Federal Teaching Hospital Abakaliki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574338
- Sponsor's protocol ID
- MSFC-2015-CT
- Status last verified
- Oct 2019
- First submitted
- 9 Oct 2015
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
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 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Ripening: A Comparison Between Intravaginal Misoprostol Tablet and Intracervical Foley's Catheter and Subsequent Induction of Labor, Safety and Efficacy in Federal Teaching Hospital Abakaliki, Ebonyi State, Nigeria.
- ClinicalTrials.gov ID
- NCT02574338
- Acronym / sponsor ID
- MSFC-2015-CT
- Conditions
- Cervical Ripening and Induction of Labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Nwali Matthew IgweOther government
- Study start
- Sep 2015 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 12 Oct 2015 (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 aim of this study is to compare the effectiveness and safety of Foley's catheter and misoprostol in cervical ripening.
Detailed description
This is a randomized clinical study which will be made up of two arms or groups. The first arm or group - 1 will have cervical ripening with intracervical extraamniotic Foley's catheter while group - 2 will have cervical ripening with intravaginal misoprostol. The parturients will be randomly selected by simple lottery and recruited into the two arms of the study. Each parturient will pick by simple lucky dip from a pool of folded papers with inscription group 1 or group 2 in a bag in a double blinded manner and will be recruited into the group picked among the two arms of the study. The Bishop's score of the cervix will be accurately determined and documented before cervical ripening. Bishop's score of ≥6 will be considered ripe. Oxytocin will be used for induction or augmentation of labor as required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group - 1 Foley's Catheter | Active comparator | Device: Foley's Catheterwill have cervical ripening with intracervical extraamniotic Foley's catheter for 24 hours |
| Group - 2 Prostaglandin E1 Analogue | Active comparator | Drug: prostaglandin E1 analoguewill have cervical ripening with intravaginal misoprostol inserted into the posterior fornix every six hours to a maximum of four doses (24 hours) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Parturients who gave consent
- has low bishop score (≤5)
- term singleton cephalic presenting fetus
- intact membranes
- no contraindication to vaginal delivery
Key exclusion criteria (9 listed)
- those who refused consent
- preterm delivery
- vaginal infection
- non-cephalic presentation
- multiple gestation
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's Catheterintracervical extraamniotic Foley's catheter | Device | group - 1 Foley's Catheter |
| prostaglandin E1 analogueAlso: Misoprostolintravaginal misoprostol | Drug | Group - 2 Prostaglandin E1 Analogue |
Primary outcome
Bishop Score of 6 or more
Time frame: 24 hours
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 15 Oct 2019.
- 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.
Related trials for Cervical Ripening and Induction of Labor
Not yet recruiting
Safety and Feasibility of the INGA Sensor System for Fetal and Uterine Monitoring During Cervical Ripening
Induced Labor, Cervical Ripening
Recruiting
Ripening Approaches for Prompt Induction and Delivery - Sequential Versus Concurrent Dilapan-S and Misoprostol to Achieve Vaginal Delivery (RAPID-DS)
Nulliparous Women Who Scheduled for Labor Induction, Pregnancy
Recruiting
Cervical Ripening Balloon, 3 Hours vs 12 Hours Placement
Labor Induction, Cervical Ripening and Induction of Labor
Recruiting
Natural Cervical Ripening to Prevent Pharmacological Induction of Labor - a Pilot Study.
Pregnancy, Induction of Labor
Active, not recruiting
Comparison of Vaginal PGE2 (Dinoprostone) and Vaginal Misoprostol for Induction of Labour in Primigravid Term Pregnancy
Labor, Induced, Term Pregnancy
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 Foley's Catheter and prostaglandin E1 analogue in people with Cervical Ripening and Induction of Labor, run by Nwali Matthew Igwe at 1 site in Nigeria.
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 9 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 15 Oct 2019. 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 Nigeria. 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?
Bishop Score of 6 or more (time frame: 24 hours). 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 NCT02574338, 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 15 Oct 2019.