Induction of Labor Affected Fetus / NewbornPhase 2NCT04533841
Propranolol and Misoprostol Versus Misoprostol Alone for Induction of Labor in Primigravidas
A Phase 2 study testing Misoprostol and Propranolol in people with Induction of Labor Affected Fetus / Newborn, run by Ahmed mohamed fathy ismail at 1 site in Egypt.
Trial summary
To compare propranolol and misoprostol versus misoprostol alone for induction of labour in primigravidas Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induction of Labor Affected Fetus / Newborn
- What is being tested?
- Misoprostol and Propranolol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2020to 15 Sep 2020
- Phase
- Phase 2
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Primigravidas.
- Full term patients with ultrasound confirmed dates.
- Singleton.
- Cephalic presentation.
- Fetal heart rate between 120 to 160 beats per minute.
Who cannot join
- • Any history of previous surgery on the uterus.
- Patients in active labour, with ruptured membranes.
- Fetal distress.
- Macrosomia or polyhydramnios
- Hypersensitivity to prostaglandins.
- Asthmatic patient .
- liver or kidney impairment .
- known cardiac patient with abnormal ECG.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Propranolol and Misoprostol Versus Misoprostol Alone for Induction of Labor In Primigravidas
To compare propranolol and misoprostol versus misoprostol alone for induction of labour in primigravidas
Read the detailed description
Candidates will be randomized into 2 groups according to a computer generated sequence. Each candidate will be assigned an opaque sealed envelope containing a paper with her group on it. Both the patient and doctor on duty will be blinded to which group the patient was assigned to.
- Study procedure:
- Written informed consent will be obtained from all participants prior to the study.
- Full history taking.
- General examination.
Patients will be subjected to the following:
- Patients attending labour room for induction of labour will be divided into two groups.
- Both groups, women are induced with Tab misoprostol 25μg applied to posterior vaginal fornix under aseptic precaution and every 6 hours for a maximum of 4 doses.
- In group 1, after induction is started with misoprostol placement, 30 minutes will pass before administration of oral Propanolol 20mg
- In group 2, after induction is started with misoprostol placement, 30 minutes will pass before administration of oral placebo in the form of sugary tablets.
- After induction, women will be monitored for fetal and maternal wellbeing and progress of labour.
- Being tested
- Misoprostol, Placebo, Propranolol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Pt will receive misoprostol for labor induction then after 30 minutes will receive ether propranolol or misoprostol
PlaceboDrug
placebo
PropranololDrug
Propranolol
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol + propranolol | Active comparator | Patient who receive misoprostol then after 30minutes receive propranolol Receives: Drug: Misoprostol; Drug: Propranolol |
| Misoprostol + placebo | Placebo comparator | Pt who will receive misoprostol then after 30minutes receive placebo Receives: Drug: Misoprostol; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction delivery interval
The time from starting induction to the delivery
Measured: procedure delivery
Secondary outcomes (1)
Mode of delivery
Vaginal delivery or cesarian section
Measured: delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start1 Feb 2020
- Primary completion13 Sep 2020
- Study completion15 Sep 2020
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 Induction of Labor Affected Fetus / NewbornStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed mohamed fathy ismail
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Sponsor-investigator, Ahmed mohamed fathy ismail, Ain Shams University
- Investigators
- Ahmed S Abd El hamid, A.professor, Study director, Ain Shams UniversityHazem A Hassan elzeneiny, Professor, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533841
- Sponsor's protocol ID
- Ahmed mohamed fathy ismail
- Status last verified
- Aug 2022
- First submitted
- 26 Aug 2020
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study results will be available
Publications
Abdel Hamid AS, El Zeneiny H, Fathy A, Nawara M. A pilot study to compare propranolol and misoprostol versus misoprostol and placebo for induction of labor in primigravidae; a randomized, single-blinded, placebo-controlled trial. BMC Pregnancy Childbirth. 2023 Apr 4;23(1):226. doi: 10.1186/s12884-023-05537-1.
PubMed 37016326
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propranolol and Misoprostol Versus Misoprostol Alone for Induction of Labor In Primigravidas
- ClinicalTrials.gov ID
- NCT04533841
- Acronym / sponsor ID
- Ahmed mohamed fathy ismail
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Ahmed mohamed fathy ismailUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 13 Sep 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 1 Sep 2020 (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.
To compare propranolol and misoprostol versus misoprostol alone for induction of labour in primigravidas
Detailed description
Candidates will be randomized into 2 groups according to a computer generated sequence. Each candidate will be assigned an opaque sealed envelope containing a paper with her group on it. Both the patient and doctor on duty will be blinded to which group the patient was assigned to.
- Study procedure:
- Written informed consent will be obtained from all participants prior to the study.
- Full history taking.
- General examination.
Patients will be subjected to the following:
- Patients attending labour room for induction of labour will be divided into two groups.
- Both groups, women are induced with Tab misoprostol 25μg applied to posterior vaginal fornix under aseptic precaution and every 6 hours for a maximum of 4 doses.
- In group 1, after induction is started with misoprostol placement, 30 minutes will pass before administration of oral Propanolol 20mg
- In group 2, after induction is started with misoprostol placement, 30 minutes will pass before administration of oral placebo in the form of sugary tablets.
- After induction, women will be monitored for fetal and maternal wellbeing and progress of labour.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Clinical trial
| Arm | Type | Receives |
|---|---|---|
| Misoprostol + propranolol | Active comparator | Drug: Misoprostol, Drug: PropranololPatient who receive misoprostol then after 30minutes receive propranolol |
| Misoprostol + placebo | Placebo comparator | Drug: Misoprostol, Drug: PlaceboPt who will receive misoprostol then after 30minutes receive placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Primigravidas.
Key exclusion criteria (8 listed)
- • Any history of previous surgery on the uterus.
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 |
|---|---|---|
| MisoprostolPt will receive misoprostol for labor induction then after 30 minutes will receive ether propranolol or misoprostol | Drug | Misoprostol + placebo, Misoprostol + propranolol |
| Placeboplacebo | Drug | Misoprostol + placebo |
| PropranololPropranolol | Drug | Misoprostol + propranolol |
Primary outcome
Induction delivery interval
Time frame: procedure delivery
The time from starting induction to the delivery
1 secondary outcome
Mode of delivery
Time frame: delivery
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 31 Aug 2022.
- Derived from this study: PubMed 37016326Abdel Hamid AS, El Zeneiny H, Fathy A, Nawara M. A pilot study to compare propranolol and misoprostol versus misoprostol and placebo for induction of labor in primigravidae; a randomized, single-blinded, placebo-controlled trial. BMC Pregnancy Childbirth. 2023 Apr 4;23(1):226. doi: 10.1186/s12884-023-05537-1.
- Individual participant dataSharing planned: Yes. Study results will be available
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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 S Abd El hamid, A.professor study director
Ain Shams University
Hazem A Hassan elzeneiny, Professor study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Misoprostol and Propranolol in people with Induction of Labor Affected Fetus / Newborn, run by Ahmed mohamed fathy ismail 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 5 inclusion and 8 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 31 Aug 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Induction delivery interval (time frame: procedure delivery). 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 NCT04533841, 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 31 Aug 2022.