Labor Onset and Length AbnormalitiesNCT06343480
Misoprostol Versus Oxytocin for Induction of Labour in Parturients With Spontaneous Rupture of Fetal Membranes at Term
A study testing Labour Induction in people with Labor Onset and Length Abnormalities, run by Federal Teaching Hospital Abakaliki at 2 sites in Nigeria.
Trial summary
Intravenous oxytocin titration has a prime position as a choice agent for induction of labour following term PROM as it has been shown to be efficacious for such purpose. Recent evidence however has shown that misoprostol is associated with better outcomes and merits evaluation in our environment. Read more about this study
- Who is it for?
- Ages 15 to 44 years, women only
- Conditions the study is for
- Labor Onset and Length Abnormalities
- What is being tested?
- Labour Induction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesNigeria
- Study dates
- 1 Sep 2020to 30 Nov 2021
- 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 15 to 44 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- signed informed consent
- singleton pregnancy at term
- prelabour rupture of membranes
- not having contraction
- Bishop scoe 5 or less
Who cannot join
- prelabour rupture of membranes at less than term
- declined consent
- contraindication for vaginal delivery
- multiple gestation
- medical conditions co-existing with pregnancy
- grand multiparous parturients
Show all 10Show fewer
- previous caesarean section scar
- already having contractions
- has intrauterine foetal death
- bishop sore >5
Trial locations and contacts
2 sites in 1 country.
Nigeria2 sites
Alex Ekwueme Federal University Teaching Hospital
Abakaliki, Ebonyi State, 480001
Federal Teaching Hospital, Abakaliki
Abakaliki, Ebonyi State, 480001
About this study
Official title: Sublingual Misoprostol Versus Oxytocin Titration for Induction of Labour in Parturients With Spontaneous Rupture of Fetal Membranes at Term: A Randomised Controlled Tial.
Intravenous oxytocin titration has a prime position as a choice agent for induction of labour following term PROM as it has been shown to be efficacious for such purpose. Recent evidence however has shown that misoprostol is associated with better outcomes and merits evaluation in our environment. This study compared the efficacy of misoprostol and oxytocin for induction of labour in parturients with term Prelabour Ruptuture of Membranes.
Read the detailed description
Induction of labour for term premature rupture of fetal membranes (PROM) is associated with greater maternal satisfaction and lower risk of maternal infection compared with expectant management. The ideal method of induction of labour for term PROM is a subject of controversy. Intravenous oxytocin titration has a prime position as a choice agent for induction of labour following term PROM as it has been shown to be efficacious for such purpose. Recent evidence however has shown that misoprostol is associated with better outcomes and merits evaluation in our environment.
This study compared the efficacy of misoprostol and oxytocin for induction of labour in parturients with term PROM. This was a double blind randomized controlled trial on the efficacy of sublingual misoprostol versus oxytocin titration in women with term PROM at the Alex Ekwueme Federal University Teaching Hospital Abakaliki (AEFUTHA) and Mile 4 Hospital Abakaliki. 240 Participants were divided into two groups of 120 participants each. Group A received 25 mcg of sublingual misoprostol and titration of 500 ml of Ringer's lactate solution as placebo with 5ml of sterile water injected into it while group B underwent immediate induction of labour with titration of 5 units of oxytocin in a 500 ml of Ringer's lactate solution and received one tablet of 100mg Vitamin C as placebo. The primary outcome measure was the mean induction delivery interval. The secondary outcome measures were Caesarean section rate, the incidence of uterine hyper-stimulation, tachysystole or hypertonus, APGAR scores at the first and fifth minute and NICU admission. Data analysis was done using statistical Package for Social Science (IBM SPSS) software (version 20, Chicago IL, USA). Continuous variables were presented as mean and standard deviation (Mean ± SD), while categorical variables were presented as numbers and percentages. Categorical variables were analyzed using Chi-square while means were compared using T-test. A difference with a P value of <0.05 was considered significant.
- Conditions
- Labor Onset and Length Abnormalities
- Being tested
- Labour Induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labour InductionDrug
Also called oxytocin titration
the use of misoprostol sublingual for labour induction compared with oxytocin titration in parturients with prelabour membrane rupture at term.
| Study group | Role | What they receive |
|---|---|---|
| first arm - Oxytocin titration | Active comparator | Received vitamin c 100mg as placebo and had Oxytocin titration in 500ml of ringers lactate for labour induction Receives: Drug: Labour Induction |
| second arm - Misoprostol give sublingual | Active comparator | received 25mcg of Misoprostol and titration of plane 500ml of ringers lactate as placebo Receives: Drug: Labour Induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean induction delivery interval
the time take from start of induction to the time of delivery of the fetus.
Measured: During the delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start1 Sep 2020
- Primary completion31 Aug 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor Onset and Length AbnormalitiesStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal Teaching Hospital Abakaliki
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nwali Matthew Igwe, Federal Teaching Hospital Abakaliki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343480
- Sponsor's protocol ID
- SMVOT2024CT
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 2 Apr 2024
- 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 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sublingual Misoprostol Versus Oxytocin Titration for Induction of Labour in Parturients With Spontaneous Rupture of Fetal Membranes at Term: A Randomised Controlled Tial.
- ClinicalTrials.gov ID
- NCT06343480
- Acronym / sponsor ID
- SMVOT2024CT
- Conditions
- Labor Onset and Length Abnormalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Federal Teaching Hospital AbakalikiOther government
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 2 Apr 2024 (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.
Intravenous oxytocin titration has a prime position as a choice agent for induction of labour following term PROM as it has been shown to be efficacious for such purpose. Recent evidence however has shown that misoprostol is associated with better outcomes and merits evaluation in our environment. This study compared the efficacy of misoprostol and oxytocin for induction of labour in parturients with term Prelabour Ruptuture of Membranes.
Detailed description
Induction of labour for term premature rupture of fetal membranes (PROM) is associated with greater maternal satisfaction and lower risk of maternal infection compared with expectant management. The ideal method of induction of labour for term PROM is a subject of controversy. Intravenous oxytocin titration has a prime position as a choice agent for induction of labour following term PROM as it has been shown to be efficacious for such purpose. Recent evidence however has shown that misoprostol is associated with better outcomes and merits evaluation in our environment.
This study compared the efficacy of misoprostol and oxytocin for induction of labour in parturients with term PROM. This was a double blind randomized controlled trial on the efficacy of sublingual misoprostol versus oxytocin titration in women with term PROM at the Alex Ekwueme Federal University Teaching Hospital Abakaliki (AEFUTHA) and Mile 4 Hospital Abakaliki. 240 Participants were divided into two groups of 120 participants each. Group A received 25 mcg of sublingual misoprostol and titration of 500 ml of Ringer's lactate solution as placebo with 5ml of sterile water injected into it while group B underwent immediate induction of labour with titration of 5 units of oxytocin in a 500 ml of Ringer's lactate solution and received one tablet of 100mg Vitamin C as placebo. The primary outcome measure was the mean induction delivery interval. The secondary outcome measures were Caesarean section rate, the incidence of uterine hyper-stimulation, tachysystole or hypertonus, APGAR scores at the first and fifth minute and NICU admission. Data analysis was done using statistical Package for Social Science (IBM SPSS) software (version 20, Chicago IL, USA). Continuous variables were presented as mean and standard deviation (Mean ± SD), while categorical variables were presented as numbers and percentages. Categorical variables were analyzed using Chi-square while means were compared using T-test. A difference with a P value of <0.05 was considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| first arm - Oxytocin titration | Active comparator | Drug: Labour InductionReceived vitamin c 100mg as placebo and had Oxytocin titration in 500ml of ringers lactate for labour induction |
| second arm - Misoprostol give sublingual | Active comparator | Drug: Labour Inductionreceived 25mcg of Misoprostol and titration of plane 500ml of ringers lactate as placebo |
Who may qualify
- Ages
- 15 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- signed informed consent
- singleton pregnancy at term
- prelabour rupture of membranes
- not having contraction
- Bishop scoe 5 or less
Key exclusion criteria (10 listed)
- prelabour rupture of membranes at less than term
- declined consent
- contraindication for vaginal delivery
- multiple gestation
- medical conditions co-existing with pregnancy
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 |
|---|---|---|
| Labour InductionAlso: oxytocin titrationthe use of misoprostol sublingual for labour induction compared with oxytocin titration in parturients with prelabour membrane rupture at term. | Drug | first arm - Oxytocin titration, second arm - Misoprostol give sublingual |
Primary outcome
Mean induction delivery interval
Time frame: During the delivery
the time take from start of induction to the time of delivery of the fetus.
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 2 Apr 2024.
Related trials for Labor Onset and Length Abnormalities
RecruitingPhase 2
Use of Cinnamomum Verum for Induction of Labor. Double Blind Randomized Clinical Trial
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Recruiting
The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL)
Labor Dystocia, Labor Complication
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Labour Induction in people with Labor Onset and Length Abnormalities, run by Federal Teaching Hospital Abakaliki at 2 sites 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 10 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 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Mean induction delivery interval (time frame: During the delivery). 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 2 Apr 2024.