Duration of LaborNCT05251610
Does Oral Propranolol Accelerate Labor Induction/Augmentation With Oxytocin in Nulliparous Women in Abakaliki?
A study testing 20mg oral propranolol and oxytocin and Oxytocin only in people with Duration of Labor, run by Darlington-Peter Chibuzor Ugoji at 1 site in Nigeria.
Trial summary
Labour is usually physiologic, spontaneous and progressive, but occasionally, there may be the need for induction or augmentation of labour especially in nulliparous women, who are at increased risk of dysfunctional labour. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Duration of Labor
- What is being tested?
- 20mg oral propranolol and oxytocin and Oxytocin only
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteNigeria
- Study dates
- 2 Nov 2020to 30 Apr 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 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Nulliparous women selected for induction or augmentation of labour
- Term pregnancy selected for induction or augmentation of labour
- Normal singleton pregnancies with cephalic presenting foetuses.
- Those who gave their consent.
Who cannot join
- Co-existing medical illnesses such as diabetes mellitus, cardiac disease, haemoglobinopathies, renal diseases, hypertensive disease, Bronchial asthma,
- Women currently taking Propranolol or a chronic beta-blocker use
- Contraindications to labour or vaginal delivery
- Multiple gestations
- Preterm labour
- Chorioamnionitis
Show all 12Show fewer
- Known fetal anomalies
- Abnormal fetal presentation.
- Antepartum haemorrhage.
- Contraindication to induction and augmentation of labour
- Multi-party
- Known allergy to propranolol
Trial locations and contacts
1 site in 1 country.
About this study
Labour is usually physiologic, spontaneous and progressive, but occasionally, there may be the need for induction or augmentation of labour especially in nulliparous women, who are at increased risk of dysfunctional labour. Oxytocin traditionally has been used for induction and augmentation of labour however prolonged labour continued to occur with attendant sequelae. Newer agents like propranolol, with minimal to no maternal and fetal adverse effects in labour have been shown to decreases the duration of labour when used in synergy with oxytocin. However, the paucity of information on the use of propranolol in labour.
Read the detailed description
ABSTRACT Background: Labour is usually physiologic, spontaneous and progressive, but occasionally, there may be the need for induction or augmentation of labour especially in nulliparous women, who are at increased risk of dysfunctional labour. Oxytocin traditionally has been used for induction and augmentation of labour however prolonged labour continued to occur with attendant sequelae. Newer agents like propranolol, with minimal to no maternal and fetal adverse effects in labour have been shown to decreases the duration of labour when used in synergy with oxytocin. However, the paucity of information on the use of propranolol in labour.
Methodology: This research was a superiority open labelled randomized controlled trial that involved only nulliparous women who met the inclusion criteria and gave consent to the study. There was daily recruitment of participants. Randomization was by utilizing computer-generated numbers from a pool of 110 participants divided into A and B. Group A received 20 mg of oral propranolol before initiation of oxytocin titration. Group B received only oxytocin titration. Partograph was used to monitor their labour.
Analysis: Absolute and relative frequencies of categorical variables, mean, range and standard deviation of continuous variables were calculated. Continuous variables were analyzed using students t-test while chi-square (χ2) test was used for categorical variables. A P-value of <0.05 was considered significant.
Keywords: Propranolol, Labour, Induction, Augmentation, Nullipara
- Conditions
- Duration of Labor
- Being tested
- 20mg oral propranolol and oxytocin, Oxytocin only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20mg oral propranolol and oxytocinDrug
Participants will receive 20mg of oral propranolol 10minutes prior to initiation of augmentation or induction of labor with oxytocin
Oxytocin onlyDrug
Participants will have outright augmentation or induction of labor with oxytocin
| Study group | Role | What they receive |
|---|---|---|
| PROPRANOLOL GROUP | Active comparator | Participants will receive 20mg of oral propranolol 10 minutes prior to initiation of augmentation or induction of labor with oxytocin Receives: Drug: 20mg oral propranolol and oxytocin |
| OXYTOCIN ONLY GROUP | Placebo comparator | Participants had outright augmentation or induction of labor with oxytocin only Receives: Drug: Oxytocin only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction/Augmentation delivery intervals at delivery
Labor acceleration at delivery
Measured: Time frame in minutes from the onset of initiation of Oxytocin to the delivery of the placenta
Secondary outcomes (2)
Maternal Blood pressure change in mmgh
Maternal Blood pressure is checked prior to initiation of oxytocin and 30 minutes after initiation of oxytocin. the difference is noted
Measured: Change over 30 minutes
Fetal heart rate change in seconds
Fetal heart rate is checked prior to initiation of oxytocin and 30 minutes after initiation of oxytocin. the difference is noted
Measured: Change over 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start2 Nov 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
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 Duration 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- clinical superiority open-labeled randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Darlington-Peter Chibuzor Ugoji
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Darlington-Peter Chibuzor Ugoji, Alex Ekwueme Federal University Teaching Hospital
- Investigators
- UGOJI DR DARLINGTON-PETER, PART 1, Principal investigator, ALEX EKWUEME FEDERAL UNIVERSITY TEACHING HOSPITAL, ABAKALIKI, EBONYI STATE, NIGERIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251610
- Sponsor's protocol ID
- FETHA/REC/VOL2/2019/277
- Status last verified
- Feb 2022
- First submitted
- 22 Sep 2021
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: until after defence of the work
Publications
Freedman SB, Adler M, Seshadri R, Powell EC. Oral ondansetron for gastroenteritis in a pediatric emergency department. N Engl J Med. 2006 Apr 20;354(16):1698-705. doi: 10.1056/NEJMoa055119.
PubMed 16625009
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Oral Propranolol Accelerate Labor Induction/Augmentation With Oxytocin in Nulliparous Women in Abakaliki?
- ClinicalTrials.gov ID
- NCT05251610
- Acronym / sponsor ID
- FETHA/REC/VOL2/2019/277
- Conditions
- Duration of Labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Darlington-Peter Chibuzor UgojiUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 23 Feb 2022 (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.
Labour is usually physiologic, spontaneous and progressive, but occasionally, there may be the need for induction or augmentation of labour especially in nulliparous women, who are at increased risk of dysfunctional labour. Oxytocin traditionally has been used for induction and augmentation of labour however prolonged labour continued to occur with attendant sequelae. Newer agents like propranolol, with minimal to no maternal and fetal adverse effects in labour have been shown to decreases the duration of labour when used in synergy with oxytocin. However, the paucity of information on the use of propranolol in labour.
Detailed description
ABSTRACT Background: Labour is usually physiologic, spontaneous and progressive, but occasionally, there may be the need for induction or augmentation of labour especially in nulliparous women, who are at increased risk of dysfunctional labour. Oxytocin traditionally has been used for induction and augmentation of labour however prolonged labour continued to occur with attendant sequelae. Newer agents like propranolol, with minimal to no maternal and fetal adverse effects in labour have been shown to decreases the duration of labour when used in synergy with oxytocin. However, the paucity of information on the use of propranolol in labour.
Methodology: This research was a superiority open labelled randomized controlled trial that involved only nulliparous women who met the inclusion criteria and gave consent to the study. There was daily recruitment of participants. Randomization was by utilizing computer-generated numbers from a pool of 110 participants divided into A and B. Group A received 20 mg of oral propranolol before initiation of oxytocin titration. Group B received only oxytocin titration. Partograph was used to monitor their labour.
Analysis: Absolute and relative frequencies of categorical variables, mean, range and standard deviation of continuous variables were calculated. Continuous variables were analyzed using students t-test while chi-square (χ2) test was used for categorical variables. A P-value of <0.05 was considered significant.
Keywords: Propranolol, Labour, Induction, Augmentation, Nullipara
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- clinical superiority open-labeled randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| PROPRANOLOL GROUP | Active comparator | Drug: 20mg oral propranolol and oxytocinParticipants will receive 20mg of oral propranolol 10 minutes prior to initiation of augmentation or induction of labor with oxytocin |
| OXYTOCIN ONLY GROUP | Placebo comparator | Drug: Oxytocin onlyParticipants had outright augmentation or induction of labor with oxytocin only |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Nulliparous women selected for induction or augmentation of labour
- Term pregnancy selected for induction or augmentation of labour
- Normal singleton pregnancies with cephalic presenting foetuses.
- Those who gave their consent.
Key exclusion criteria (12 listed)
- Co-existing medical illnesses such as diabetes mellitus, cardiac disease, haemoglobinopathies, renal diseases, hypertensive disease, Bronchial asthma,
- Women currently taking Propranolol or a chronic beta-blocker use
- Contraindications to labour or vaginal delivery
- Multiple gestations
- Preterm labour
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 |
|---|---|---|
| 20mg oral propranolol and oxytocinParticipants will receive 20mg of oral propranolol 10minutes prior to initiation of augmentation or induction of labor with oxytocin | Drug | PROPRANOLOL GROUP |
| Oxytocin onlyParticipants will have outright augmentation or induction of labor with oxytocin | Drug | OXYTOCIN ONLY GROUP |
Primary outcome
Induction/Augmentation delivery intervals at delivery
Time frame: Time frame in minutes from the onset of initiation of Oxytocin to the delivery of the placenta
Labor acceleration at delivery
2 secondary outcomes
Maternal Blood pressure change in mmgh
Time frame: Change over 30 minutes
Fetal heart rate change in seconds
Time frame: Change over 30 minutes
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 23 Feb 2022.
- Background: PubMed 16625009Freedman SB, Adler M, Seshadri R, Powell EC. Oral ondansetron for gastroenteritis in a pediatric emergency department. N Engl J Med. 2006 Apr 20;354(16):1698-705. doi: 10.1056/NEJMoa055119.
- Individual participant dataSharing planned: No. until after defence of the work
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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.
UGOJI DR DARLINGTON-PETER, PART 1 principal investigator
ALEX EKWUEME FEDERAL UNIVERSITY TEACHING HOSPITAL, ABAKALIKI, EBONYI STATE, NIGERIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 20mg oral propranolol and oxytocin and Oxytocin only in people with Duration of Labor, run by Darlington-Peter Chibuzor Ugoji 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 4 inclusion and 12 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 23 Feb 2022. 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. Some participants in this study may receive a placebo. 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?
Induction/Augmentation delivery intervals at delivery (time frame: Time frame in minutes from the onset of initiation of Oxytocin to the delivery of the placenta). 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 NCT05251610, 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 23 Feb 2022.