PropranololNCT06960850
Effects of Oral Propranolol on Induction-Delivery Interval During Induction of Labour With Oxytocin
A study testing Propranolol in people with Propranolol and Labour Induction, run by Federal Teaching Hospital Abakaliki at 1 site in Nigeria.
Trial summary
Prolonged pregnancy could lead to perinatal and maternal complications. Oxytocin has been wildly used for induction of labour, but prolonged labour continued to occur with its attendant sequelae. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Propranolol, Labour Induction
- What is being tested?
- Propranolol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 308 participants
- Where
- 1 siteNigeria
- Study dates
- 1 Jun 2025to 1 Dec 2025
- 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 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- singleton foetus
- cephalic presentation at term
Who cannot join
- Patients on beta blockers
- Contraindications to labour or vaginal delivery
- Multiple gestations
- Preterm labour
- Chorioamnionitis
- Known fetal anomalies
Show all 12Show fewer
- Bronchial asthma
- Abnormal fetal presentation.
- Antepartum haemorrhage.
- Lung disease
- Previous uterine scar or surgery.
- Foetal heart irregularity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nigeria1 site
Alex Ekwueme Federal University Teaching Hospital
Abakaliki, Ebonyi State, 480101
About this study
Official title: A Randomized Controlled Trial on the Effect of Oral Propranolol on Induction-Delivery Interval in Women Undergoing Oxytocin Induction of Labour in Abakaliki
Prolonged pregnancy could lead to perinatal and maternal complications. Oxytocin has been wildly used for induction of labour, but prolonged labour continued to occur with its attendant sequelae. Propranolol, a non-selective B-adrenergic inhibitor has been found to facilitate labour progress in some studies, by the blockade of the effects of catecholamines on the uterus though there are conflicting reports, with the only meta-analysis inconclusive due to few studies used; hence, the need to further study its role in induction of labour. The aim of this study is to assess the role of oral Propranolol in decreasing the induction-delivery with oxytocin
Read the detailed description
Background: Prolonged pregnancy could lead to perinatal and maternal complications. To prevent this, induction of labour becomes necessary. Conventionally, oxytocin has been wildly used for induction of labour, but prolonged labour continued to occur with its attendant sequelae. Propranolol, a non-selective B-adrenergic inhibitor has been found to facilitate labour progress in some studies, by the blockade of the effects of catecholamines on the uterus though there are conflicting reports, with the only meta-analysis inconclusive due to few studies used; hence, the need to further study its role in induction of labour.
Aim: The aim of this study is to assess the role of oral Propranolol in decreasing the induction-delivery with oxytocin.
Methodology: This will be double-blind, superiority randomised controlled trial involving pregnant women at term who meet the inclusion criteria and consent to the study over a six-month period. The participants will be randomised by means of computer-generated numbers from a pool of 308 participants. A set of 154 numbers will receive oxytocin + propranolol once/twice 6 hours apart, starting from 10 minutes before commencement of oxytocin titration; while the other set of 154 numbers would be given oxytocin + placebo once/twice 6 hours apart, starting from 10 minutes before commencement of oxytocin titration.Labour will be monitored with the labour care guide.
- Conditions
- Propranolol, Labour Induction
- Being tested
- Propranolol, Placebo
- Keywords
- Propanolol, Induction-Delivery, Oxytocin, Labour Induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
A set of 154 numbers will receive oxytocin and propranolol once or twice 6 hours apart. the first dose will be from 10 minutes before commencement of oxytocin titration and the second dose will be 6 hours from the first dose if delivery has not taken place.
PlaceboOther
A set of 154 numbers will receive oxytocin and placebo once or twice 6 hours apart. the first dose will be from 10 minutes before commencement of oxytocin titration and the second dose will be 6 hours from the first dose if delivery has not taken place.
| Study group | Role | What they receive |
|---|---|---|
| Propranolol | Experimental | A set of 154 numbers will receive oxytocin and propranolol once or twice 6 hours apart. The first dose will be from 10 minutes before commencement of oxytocin titration and the second dose will be 6 hours from the first dose if delivery has not taken place. Receives: Drug: Propranolol |
| Placebo | Placebo comparator | A set of 154 numbers will receive oxytocin and placebo once or twice 6 hours apart. The first dose will be from 10 minutes before commencement of oxytocin titration and the second dose will be 6 hours from the first dose if delivery has not taken place. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean duration of first, second and third stage of labour
this is to assess the mean duration of the first, second and third stages of labour
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 posted7 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PropranololStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal Teaching Hospital Abakaliki
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Assumpta Nnenna Nweke, Federal Teaching Hospital Abakaliki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960850
- Sponsor's protocol ID
- AE-FUTHA/REC/VOL3/2024/409
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Effect of Oral Propranolol on Induction-Delivery Interval in Women Undergoing Oxytocin Induction of Labour in Abakaliki
- ClinicalTrials.gov ID
- NCT06960850
- Acronym / sponsor ID
- AE-FUTHA/REC/VOL3/2024/409
- Conditions
- Propranolol, Labour Induction
- Keywords
- Propanolol, Induction-Delivery, Oxytocin, Labour Induction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Federal Teaching Hospital AbakalikiOther government
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 7 May 2025 (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.
Prolonged pregnancy could lead to perinatal and maternal complications. Oxytocin has been wildly used for induction of labour, but prolonged labour continued to occur with its attendant sequelae. Propranolol, a non-selective B-adrenergic inhibitor has been found to facilitate labour progress in some studies, by the blockade of the effects of catecholamines on the uterus though there are conflicting reports, with the only meta-analysis inconclusive due to few studies used; hence, the need to further study its role in induction of labour. The aim of this study is to assess the role of oral Propranolol in decreasing the induction-delivery with oxytocin
Detailed description
Background: Prolonged pregnancy could lead to perinatal and maternal complications. To prevent this, induction of labour becomes necessary. Conventionally, oxytocin has been wildly used for induction of labour, but prolonged labour continued to occur with its attendant sequelae. Propranolol, a non-selective B-adrenergic inhibitor has been found to facilitate labour progress in some studies, by the blockade of the effects of catecholamines on the uterus though there are conflicting reports, with the only meta-analysis inconclusive due to few studies used; hence, the need to further study its role in induction of labour.
Aim: The aim of this study is to assess the role of oral Propranolol in decreasing the induction-delivery with oxytocin.
Methodology: This will be double-blind, superiority randomised controlled trial involving pregnant women at term who meet the inclusion criteria and consent to the study over a six-month period. The participants will be randomised by means of computer-generated numbers from a pool of 308 participants. A set of 154 numbers will receive oxytocin + propranolol once/twice 6 hours apart, starting from 10 minutes before commencement of oxytocin titration; while the other set of 154 numbers would be given oxytocin + placebo once/twice 6 hours apart, starting from 10 minutes before commencement of oxytocin titration.Labour will be monitored with the labour care guide.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propranolol | Experimental | Drug: PropranololA set of 154 numbers will receive oxytocin and propranolol once or twice 6 hours apart. The first dose will be from 10 minutes before commencement of oxytocin titration and the second dose will be 6 hours from the first dose if delivery has not taken place. |
| Placebo | Placebo comparator | Other: PlaceboA set of 154 numbers will receive oxytocin and placebo once or twice 6 hours apart. The first dose will be from 10 minutes before commencement of oxytocin titration and the second dose will be 6 hours from the first dose if delivery has not taken place. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- singleton foetus
- cephalic presentation at term
Key exclusion criteria (12 listed)
- Patients on beta blockers
- Contraindications to labour or vaginal delivery
- Multiple gestations
- Preterm labour
- Chorioamnionitis
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 |
|---|---|---|
| PropranololA set of 154 numbers will receive oxytocin and propranolol once or twice 6 hours apart. the first dose will be from 10 minutes before commencement of oxytocin titration and the second dose will be 6 hours from the first dose if delivery has not taken place. | Drug | Propranolol |
| PlaceboA set of 154 numbers will receive oxytocin and placebo once or twice 6 hours apart. the first dose will be from 10 minutes before commencement of oxytocin titration and the second dose will be 6 hours from the first dose if delivery has not taken place. | Other | Placebo |
Primary outcome
Mean duration of first, second and third stage of labour
Time frame: 24 hours
this is to assess the mean duration of the first, second and third stages of labour
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 7 May 2025.
- 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.
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 Propranolol in people with Propranolol and Labour Induction, run by Federal Teaching Hospital Abakaliki 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 2 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: opening soon, as of the sponsor's last update on 7 May 2025. 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?
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?
Mean duration of first, second and third stage of labour (time frame: 24 hours). 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 7 May 2025.