Vaginal DeliveryPhase 4NCT02824679
Effect of Intravenous Hyoscine Butylbromide Injection on First Stage Labour in Primigavidae
A Phase 4 study testing hyoscine butylbromide and saline in people with Vaginal Delivery, run by Ahmed M Maged, MD.
Trial summary
A case control study conducted on 120 women coming to Cairo University Maternity Hospital .Patients who meet the inclusion criteria were asked to participate in the study and a verbal consent was obtained from each patient. Patients will be divided into three equal groups (A, B, C). Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Vaginal Delivery
- What is being tested?
- hyoscine butylbromide and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Mar 2017
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18 - 35 years old
- Primigravdae.
- Gestational age between completed 37- 41 weeks + 6 days.
- Uncomplicated cephalic singleton pregnancy occipto-anterior position.
- Established spontaneous active labour (defined as the presence of at least three regular uterine contractions over 10 minutes with cervical dilatation three to four centimeters) with cervical effacement not less than 50%.
- Intact amniotic membranes.
Who cannot join
- Multigravidae.
- Multiple fetus.
- Malpresentation.
- Patients with indications of elective caesarean section.
- Medical conditions associated with pregnancy e.g. preeclampsia, diabetes mellitus.
- Contraindications for hyoscine butylbromide which include known allergy to hyoscine or other atropinics (e.g., atropine, scopolamine), myasthenia gravis, megacolon or glaucoma.
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- Patients presented to causality with spontaneous rupture of membranes.
- Spontaneous rupture of membranes during the active phase of first stage of labour.
- Oxytocin induction or augmentation.
- Patients who underwent epidural anesthesia or other types of analgesia.
About this study
Official title: Effect of Intravenous Hyoscine Butylbromide Injection on the Course and Duration of First Stage of Labour in Primigavidae
A case control study conducted on 120 women coming to Cairo University Maternity Hospital .Patients who meet the inclusion criteria were asked to participate in the study and a verbal consent was obtained from each patient. Patients will be divided into three equal groups (A, B, C). A single dose of the drug (placebo or HBB 20mg or HBB 40 mg) will be injected intravenously slowly to groups A, B, C respectively. Labouring mothers will be monitored in bed. Vaginal examination will be conducted every two hours. The duration of the first stage was calculated from the time of cervical dilatation of three to four centimeters in active labour until a fully dilated cervix will be observed
Read the detailed description
A case control study conducted on 120 women coming to Cairo University Maternity Hospital .Patients who meet the inclusion criteria were asked to participate in the study and a verbal consent was obtained from each patient. Patients will be divided into three equal groups (A, B, C). A single dose of the drug (placebo or HBB 20mg or HBB 40 mg) will be injected intravenously slowly to groups A, B, C respectively. Labouring mothers will be monitored in bed. Vaginal examination will be conducted every two hours. The duration of the first stage was calculated from the time of cervical dilatation of three to four centimeters in active labour until a fully dilated cervix will be observed
- Conditions
- Vaginal Delivery
- Being tested
- hyoscine butylbromide, saline
- Keywords
- Normal labour, Augmentation of labour, Hyoscine butylbromide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyoscine butylbromideDrug
20 - 40 mg of hyoscine butylbromide is given intravenously during the first stage of labor
salineDrug
0.9%normal saline
| Study group | Role | What they receive |
|---|---|---|
| 20mg hyoscine butylbromide | Active comparator | They received (20mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously Receives: Drug: hyoscine butylbromide; Drug: saline |
| 40 mg hyoscine butylbromide | Active comparator | They received (40mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously Receives: Drug: hyoscine butylbromide |
| Saline | Placebo comparator | They received two ml of normal saline intravenously as a placebo Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
first stage duration
time till cervix become fully dilated
Measured: 12 hours after drug intake
Secondary outcomes (1)
Mode of delivery
Normal vaginal or cesarean section
Measured: 12 hours after drug intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startJul 2015
- Primary completionDec 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal DeliveryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed M Maged, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, Kasr Alainy medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824679
- Sponsor's protocol ID
- 150
- Status last verified
- Dec 2021
- First submitted
- 2 Jul 2016
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Hyoscine Butylbromide Injection on the Course and Duration of First Stage of Labour in Primigavidae
- ClinicalTrials.gov ID
- NCT02824679
- Acronym / sponsor ID
- 150
- Conditions
- Vaginal Delivery
- Keywords
- Normal labour, Augmentation of labour, Hyoscine butylbromide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ahmed M Maged, MDUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 7 Jul 2016 (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.
A case control study conducted on 120 women coming to Cairo University Maternity Hospital .Patients who meet the inclusion criteria were asked to participate in the study and a verbal consent was obtained from each patient. Patients will be divided into three equal groups (A, B, C). A single dose of the drug (placebo or HBB 20mg or HBB 40 mg) will be injected intravenously slowly to groups A, B, C respectively. Labouring mothers will be monitored in bed. Vaginal examination will be conducted every two hours. The duration of the first stage was calculated from the time of cervical dilatation of three to four centimeters in active labour until a fully dilated cervix will be observed
Detailed description
A case control study conducted on 120 women coming to Cairo University Maternity Hospital .Patients who meet the inclusion criteria were asked to participate in the study and a verbal consent was obtained from each patient. Patients will be divided into three equal groups (A, B, C). A single dose of the drug (placebo or HBB 20mg or HBB 40 mg) will be injected intravenously slowly to groups A, B, C respectively. Labouring mothers will be monitored in bed. Vaginal examination will be conducted every two hours. The duration of the first stage was calculated from the time of cervical dilatation of three to four centimeters in active labour until a fully dilated cervix will be observed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 20mg hyoscine butylbromide | Active comparator | Drug: hyoscine butylbromide, Drug: salineThey received (20mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously |
| 40 mg hyoscine butylbromide | Active comparator | Drug: hyoscine butylbromideThey received (40mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously |
| Saline | Placebo comparator | Drug: salineThey received two ml of normal saline intravenously as a placebo |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age: 18 - 35 years old
- Primigravdae.
- Gestational age between completed 37- 41 weeks + 6 days.
- Uncomplicated cephalic singleton pregnancy occipto-anterior position.
- Established spontaneous active labour (defined as the presence of at least three regular uterine contractions over 10 minutes with cervical dilatation three to four centimeters) with cervical effacement not less than 50%.
Key exclusion criteria (10 listed)
- Multigravidae.
- Multiple fetus.
- Malpresentation.
- Patients with indications of elective caesarean section.
- Medical conditions associated with pregnancy e.g. preeclampsia, diabetes mellitus.
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 |
|---|---|---|
| hyoscine butylbromide20 - 40 mg of hyoscine butylbromide is given intravenously during the first stage of labor | Drug | 20mg hyoscine butylbromide, 40 mg hyoscine butylbromide |
| saline0.9%normal saline | Drug | 20mg hyoscine butylbromide, Saline |
Primary outcome
first stage duration
Time frame: 12 hours after drug intake
time till cervix become fully dilated
1 secondary outcome
Mode of delivery
Time frame: 12 hours after drug intake
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 14 Dec 2021.
- Individual participant dataSharing planned: Yes
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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.
Ahmed Maged, MD principal investigator
Kasr Alainy medical school
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hyoscine butylbromide and saline in people with Vaginal Delivery, run by Ahmed M Maged, MD.
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 6 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 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
first stage duration (time frame: 12 hours after drug intake). 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 14 Dec 2021.