Vaginal DeliveryPhase 4NCT03055390
Effect of Intravenous Hyoscine Butylbromide Injection on Labour in High Risk Women
A Phase 4 study testing hyoscine butylbromide in people with Vaginal Delivery, run by Cairo University at 1 site in Egypt.
Trial summary
A case control trial Patients who meet the inclusion criteria were asked to participate in the study and a written consent was obtained from each patient after explaining thoroughly the nature and the scope of the study. Patients were divided into three equal groups: Group A: included 40 pregnant patients. 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
- Vaginal Delivery
- What is being tested?
- hyoscine butylbromide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Feb 2017to 3 Feb 2022
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 - 35 years old
- Primigravdae or multigravida
- 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.
- High risk pregnancy (women with pregnancy induced hypertension- cardiac-Diabetes Mellitus
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study the Effect of Intravenous Hyoscine Butylbromide Injection on the Duration and Progress of First Stage Labour in High Risk Women
A case control trial Patients who meet the inclusion criteria were asked to participate in the study and a written consent was obtained from each patient after explaining thoroughly the nature and the scope of the study.
Patients were divided into three equal groups:
Group A: included 40 pregnant patients. They received two ml of normal saline intravenously as a placebo.
Group B: included 40 pregnant patients. They received (20mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously.
Group C: included 40 pregnant patients .They received two ml (40 mg) hyoscine butylbromide intravenously (HBB).
Read the detailed description
A case control trial Patients who meet the inclusion criteria were asked to participate in the study and a written consent was obtained from each patient after explaining thoroughly the nature and the scope of the study.
For each patient:
- Complete history was taking to exclude allergy to hyoscine butylbromide, medical disorders with pregnancy (preeclampsia, diabetes mellitus, heart disease …etc.) and any contraindication for vaginal delivery.
- General examination of the patients including (pulse, blood pressure, temperature).
- Obstetric Abdominal examination including fetal lie, fetal presentation, head station and uterine contractions.
- Vaginal examination including cervical dilatation, effacement and position, state of fetal membranes, presenting part, position of fetal head and pelvic adequacy.
- Obstetric ultrasound to detect fetal gestational age, fetal birth weight amount of liquor, site of placental attachment and fetal heart rate.
Patients were divided into three equal groups:
Group A: included 40 pregnant patients. They received two ml of normal saline intravenously as a placebo.
Group B: included 40 pregnant patients. They received (20mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously.
Group C: included 40 pregnant patients .They received two ml (40 mg) hyoscine butylbromide intravenously (HBB).
- Conditions
- Vaginal Delivery
- Being tested
- hyoscine butylbromide, placebo
- Keywords
- hyoscine butylbromide, progress of labor, duration of labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyoscine butylbromideDrug
Also called Dospa
Intravenous administration of hyoscine butylbromide during first stage of labor
placeboDrug
Also called saline
2ml of saline intravenous
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | They received two ml of normal saline intravenously as a placebo Receives: Drug: placebo |
| 20 mg hyoscine butylbromide | Active comparator | They received (20mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously Receives: Drug: hyoscine butylbromide |
| 40 mg hyoscine butylbromide | Active comparator | They received (40mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously Receives: Drug: hyoscine butylbromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the first stage of labour
Duration of the first stage 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 posted16 Feb 2017
- Study start11 Feb 2017
- Primary completion10 Jan 2022
- Study completion3 Feb 2022
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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed Maged, Principal investigator, Kasr Alainy medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055390
- Sponsor's protocol ID
- 158
- Status last verified
- Mar 2022
- First submitted
- 14 Feb 2017
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study the Effect of Intravenous Hyoscine Butylbromide Injection on the Duration and Progress of First Stage Labour in High Risk Women
- ClinicalTrials.gov ID
- NCT03055390
- Acronym / sponsor ID
- 158
- Conditions
- Vaginal Delivery
- Keywords
- hyoscine butylbromide, progress of labor, duration of labor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 11 Feb 2017 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 3 Feb 2022 (actual)
- First posted
- 16 Feb 2017 (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.
A case control trial Patients who meet the inclusion criteria were asked to participate in the study and a written consent was obtained from each patient after explaining thoroughly the nature and the scope of the study.
Patients were divided into three equal groups:
Group A: included 40 pregnant patients. They received two ml of normal saline intravenously as a placebo.
Group B: included 40 pregnant patients. They received (20mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously.
Group C: included 40 pregnant patients .They received two ml (40 mg) hyoscine butylbromide intravenously (HBB).
Detailed description
A case control trial Patients who meet the inclusion criteria were asked to participate in the study and a written consent was obtained from each patient after explaining thoroughly the nature and the scope of the study.
For each patient:
- Complete history was taking to exclude allergy to hyoscine butylbromide, medical disorders with pregnancy (preeclampsia, diabetes mellitus, heart disease …etc.) and any contraindication for vaginal delivery.
- General examination of the patients including (pulse, blood pressure, temperature).
- Obstetric Abdominal examination including fetal lie, fetal presentation, head station and uterine contractions.
- Vaginal examination including cervical dilatation, effacement and position, state of fetal membranes, presenting part, position of fetal head and pelvic adequacy.
- Obstetric ultrasound to detect fetal gestational age, fetal birth weight amount of liquor, site of placental attachment and fetal heart rate.
Patients were divided into three equal groups:
Group A: included 40 pregnant patients. They received two ml of normal saline intravenously as a placebo.
Group B: included 40 pregnant patients. They received (20mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously.
Group C: included 40 pregnant patients .They received two ml (40 mg) hyoscine butylbromide intravenously (HBB).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: placeboThey received two ml of normal saline intravenously as a placebo |
| 20 mg hyoscine butylbromide | Active comparator | Drug: hyoscine butylbromideThey 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age: 18 - 35 years old
- Primigravdae or multigravida
- 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 butylbromideAlso: DospaIntravenous administration of hyoscine butylbromide during first stage of labor | Drug | 20 mg hyoscine butylbromide, 40 mg hyoscine butylbromide |
| placeboAlso: saline2ml of saline intravenous | Drug | Control |
Primary outcome
Duration of the first stage of labour
Time frame: 24 hours
Duration of the first stage 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 10 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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 principal investigator
Kasr Alainy medical school
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hyoscine butylbromide in people with Vaginal Delivery, run by Cairo University at 1 site in Egypt.
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 7 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 10 Mar 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 Egypt. 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.
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?
Duration of the first 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 10 Mar 2022.