Labour DurationNCT07474350
Valethamate Bromide Versus Hyoscine Butyl Bromide in Reducing Labour Duration Among Primigravida
A study testing Valethamate Bromide, Hyoscine butylbromide and Sterile water in people with Labour Duration and Primigravida, run by Federal Teaching Hospital Abakaliki at 1 site in Nigeria.
Trial summary
Labour is a physiological process that enables the natural delivery of fetus, placenta and membranes after the age of viability. This study compared the efficacy of valethamate bromide and hyoscine butyl bromide in reducing labour duration among primigravid women at Alex Ekwueme Federal University Teaching Hospital… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labour Duration, Primigravida
- What is being tested?
- Valethamate Bromide, Hyoscine butylbromide and Sterile water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteNigeria
- Study dates
- 1 Sep 2023to 23 Jan 2024
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primigravidae / nulliparae.
- Singleton term pregnancy with no evidence of maternal or fetal distress.
- Women with fetus in cephalic presentation.
- Age: 18- 35 years.
- Women with no contra-indications to vaginal delivery.
- Cervical dilatations of 4- 9cm when in labour
- Spontaneous or induced labour.
- Patients on epidural analgesia
Who cannot join
- Multiple gestations.
- Women with abnormal fetal presentation.
- Absolute indications for caesarean section.
- Antepartum hemorrhage.
- Evidence of maternal or fetal distress.
- Fibroid in pregnancy.
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- Grand multiparous patients.
- Previous uterine scar/ surgery or ruptures.
- Medical disorders of pregnancy like pre-eclempsia, Eclempsia, Dm etc.
- If any other antispasmodics agent had been used within the last 48 hours.
- Preterm/ term premature rupture of membranes.
- History of cervical injury/ surgery.
- Hypersensitivity to valethamate bromide and/or hyoscine butyl bromide
Trial locations and contacts
1 site in 1 country.
Nigeria1 site
Alex Ekwueme Federal University Teaching Hospital
Abakaliki, Ebonyi State, 480101
About this study
Official title: Valethamate Bromide Versus Hyoscine Butyl Bromide in Reducing Labour Duration Among Primigravida: A Randomised Controlled Trial.
Labour is a physiological process that enables the natural delivery of fetus, placenta and membranes after the age of viability.
This study compared the efficacy of valethamate bromide and hyoscine butyl bromide in reducing labour duration among primigravid women at Alex Ekwueme Federal University Teaching Hospital, Abakaliki
Read the detailed description
Labour is a physiological process that enables the natural delivery of fetus, placenta and membranes after the age of viability. When labour is prolonged, it may defeat the whole essence of pregnancy as a result of poor outcome. Efforts have been made to prevent prolonged labour which includes the use of certain medications such as hyoscinebutyl bromide and valethamate bromide. However, there is paucity of studies comparing the effectiveness of both drugs, which could provide a better choice of reducing labour duration and its attendants' complications.
AIM:
This study compared the efficacy of valethamate bromide and hyoscine butyl bromide in reducing labour duration among primigravid women at Alex Ekwueme Federal University Teaching Hospital, Abakaliki.
RESEARCH METHOD:
This was a randomized controlled study where equal members of primigravid women at term were recruited and received 8 mg (2 ml) of valethamatebromide;20 mg (2 ml) of hyoscine butyl bromideand 2ml of sterile water.
Either valethamate bromide 8mg, hyoscine butyl bromide20mg and no intervention (2 ml of sterile water) were given intravenously to the women who met the criteria. The data obtained were analyzed using statistical package for social science (SPSS) software (version 2022, Chicago II, USA). Categorical variables were presented as numbers and percentages while continuous variables were presented as mean and standard deviation (mean + 25D). Logistic regression was used where appropriate. A difference with a P value of ≤ 0.05 was taken to be statistically significant.
- Conditions
- Labour Duration, Primigravida
- Being tested
- Valethamate Bromide, Hyoscine butylbromide, Sterile water
- Keywords
- Valethamate bromide, Hyoscine butyl bromide, Primigravida, Labour duration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valethamate BromideDrug
Two ml (16mg) of valethamate bromide was given intravenously to the patient who has attained active phase labour parameters
Hyoscine butylbromideDrug
Two ml (40mg) of hyoscine butylbromide was given intravenously to the patient who has attained active phase labour parameters
Sterile waterOther
Two ml of water was given intravenously to the patient who has attained active phase labour parameters
| Study group | Role | What they receive |
|---|---|---|
| Valethamate | Experimental | Group I received 2ml (16mg) of valethamate bromide intravenously, when patient is in active phase of labour. Receives: Drug: Valethamate Bromide |
| Hyoscine | Active comparator | Group II received 2ml (40mg) of hyoscine butyl bromide intravenously when patient is in active phase of labour. Receives: Drug: Hyoscine butylbromide |
| Water | Sham comparator | Group III received 2ml of sterile water for injection when patient is in active phase of labour Receives: Other: Sterile water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of cervical dilatation
This was the rate of dilation of the cervix per hour in patients in active phase of labour
Measured: 8hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Sep 2023
- Primary completion23 Jan 2024
- Study completion23 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labour DurationStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal Teaching Hospital Abakaliki
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Assumpta Nnenna Nweke, Federal Teaching Hospital Abakaliki
- Investigators
- Assumpta N Nweke, Principal investigator, Alex Ekwueme Federal University Teaching Hospital Abakaliki Ebonyi State
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474350
- Sponsor's protocol ID
- AE FUTHA/REC/VOL3/2023/236
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This will be after publication
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valethamate Bromide Versus Hyoscine Butyl Bromide in Reducing Labour Duration Among Primigravida: A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT07474350
- Acronym / sponsor ID
- AE FUTHA/REC/VOL3/2023/236
- Conditions
- Labour Duration, Primigravida
- Keywords
- Valethamate bromide, Hyoscine butyl bromide, Primigravida, Labour duration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Federal Teaching Hospital AbakalikiOther government
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 23 Jan 2024 (actual)
- First posted
- 16 Mar 2026 (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 a physiological process that enables the natural delivery of fetus, placenta and membranes after the age of viability.
This study compared the efficacy of valethamate bromide and hyoscine butyl bromide in reducing labour duration among primigravid women at Alex Ekwueme Federal University Teaching Hospital, Abakaliki
Detailed description
Labour is a physiological process that enables the natural delivery of fetus, placenta and membranes after the age of viability. When labour is prolonged, it may defeat the whole essence of pregnancy as a result of poor outcome. Efforts have been made to prevent prolonged labour which includes the use of certain medications such as hyoscinebutyl bromide and valethamate bromide. However, there is paucity of studies comparing the effectiveness of both drugs, which could provide a better choice of reducing labour duration and its attendants' complications.
AIM:
This study compared the efficacy of valethamate bromide and hyoscine butyl bromide in reducing labour duration among primigravid women at Alex Ekwueme Federal University Teaching Hospital, Abakaliki.
RESEARCH METHOD:
This was a randomized controlled study where equal members of primigravid women at term were recruited and received 8 mg (2 ml) of valethamatebromide;20 mg (2 ml) of hyoscine butyl bromideand 2ml of sterile water.
Either valethamate bromide 8mg, hyoscine butyl bromide20mg and no intervention (2 ml of sterile water) were given intravenously to the women who met the criteria. The data obtained were analyzed using statistical package for social science (SPSS) software (version 2022, Chicago II, USA). Categorical variables were presented as numbers and percentages while continuous variables were presented as mean and standard deviation (mean + 25D). Logistic regression was used where appropriate. A difference with a P value of ≤ 0.05 was taken to be statistically significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Valethamate | Experimental | Drug: Valethamate BromideGroup I received 2ml (16mg) of valethamate bromide intravenously, when patient is in active phase of labour. |
| Hyoscine | Active comparator | Drug: Hyoscine butylbromideGroup II received 2ml (40mg) of hyoscine butyl bromide intravenously when patient is in active phase of labour. |
| Water | Sham comparator | Other: Sterile waterGroup III received 2ml of sterile water for injection when patient is in active phase of labour |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Primigravidae / nulliparae.
- Singleton term pregnancy with no evidence of maternal or fetal distress.
- Women with fetus in cephalic presentation.
- Age: 18- 35 years.
- Women with no contra-indications to vaginal delivery.
Key exclusion criteria (13 listed)
- Multiple gestations.
- Women with abnormal fetal presentation.
- Absolute indications for caesarean section.
- Antepartum hemorrhage.
- Evidence of maternal or fetal distress.
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 |
|---|---|---|
| Valethamate BromideTwo ml (16mg) of valethamate bromide was given intravenously to the patient who has attained active phase labour parameters | Drug | Valethamate |
| Hyoscine butylbromideTwo ml (40mg) of hyoscine butylbromide was given intravenously to the patient who has attained active phase labour parameters | Drug | Hyoscine |
| Sterile waterTwo ml of water was given intravenously to the patient who has attained active phase labour parameters | Other | Water |
Primary outcome
Rate of cervical dilatation
Time frame: 8hours
This was the rate of dilation of the cervix per hour in patients in active phase of labour
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 16 Mar 2026.
- Individual participant dataSharing planned: No. This will be after publication
Related trials for Labour Duration
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding
Not yet recruiting
The Effects of Adjunctive Therapy With Vaginal Tablets Lactobacillus Acidophilus and a Low Dose Estriol (Gynoflor®) to Prolong Pregnancy Time in Preterm Labor, A Randomized Controlled Trial
Threaten Preterm, Prethrem Labour
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.
Assumpta N Nweke principal investigator
Alex Ekwueme Federal University Teaching Hospital Abakaliki Ebonyi State
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valethamate Bromide, Hyoscine butylbromide and Sterile water in people with Labour Duration and Primigravida, 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 8 inclusion and 13 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 16 Mar 2026. 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?
Rate of cervical dilatation (time frame: 8hours). 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 16 Mar 2026.