Poor; LaborPhase 3NCT02702674
The Effect of Coadministration of Oral Propranolol to Oxytocin on Induction of Labor
A Phase 3 study testing propranolol and Oxytocin in people with Poor; Labor, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
The effect of coadministration of oral propranolol to oxytocin on induction of labor. Read more about this study
- Who is it for?
- Ages 17 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Poor; Labor
- What is being tested?
- propranolol and Oxytocin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 242 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2015to Dec 2016
- Phase
- Phase 3
- 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 17 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Gestational age above 37 weeks.
- Fetal life positive on ultrasound.
- Bishop score > 5.
- Primiparous women.
Who cannot join
- history of uterine surgery
- polyhydramnios
- contraindications to β-adrenergic agents, such as systolic blood pressure less than 100 mmHg or pulse rate less than 60/min and more than 120/min
- history of any known cardiac disease
- mother's pulmonary or metabolic disorders
- fetal distress
- estimated weight of the fetus more than 4 kg by ultrasound of cephalic presentation
Trial locations and contacts
1 site in 1 country.
About this study
The effect of coadministration of oral propranolol to oxytocin on induction of labor.
Read the detailed description
Study hypothesis:
Oral propranolol when used with oxytocin during the process of labor may reduce labor interval and decrease the rate of cesarean delivery.
Study population:
The patients will be recruited from the women attending obstetrics reception room, in Ain Shams University Maternity Hospital.
Intervention:
After taking informed consent, all patients recruited in the study will undergo complete clinical examination and detailed medical history will be obtained along with necessary laboratory investigations and ultrasound. Each patient will have a case record form in which the following data will be recorded:
- History: personal (age, duration of marriage), present illness (any current medical or surgical diseases and any current medication), obstetric history (including parity, gestational age, obstetric complications) and past medical history(especially cardiac problems).
- Clinical examination:
- General examination: assessment of vital data, cardiac and chest auscultation to exclude contraindications for drug administration.
- Abdominal examination: assessment of fundal level and contractions if present.
- Pelvic examination: assessment of Bishop score, membrane status and fetal presentation.
- Investigations:
- Routine investigations will be done e.g., Full blood count, CRP titre.
- Pelvi-abdominal U/S (confirm fetal life, placental location, fetus parameters, amniotic fluid index, expected fetal weight).
Steps:
- Informed consent will be obtained from parents or guardians of patients who are invited to participate in the research after explanation of benefits and risks of this trial.
- A capsule containing 20 mg propranolol to the first group (propranolol plus oxytocin) and a similar capsule as a placebo to the second group (oxytocin plus placebo) are administrated orally before beginning induction. Oral capsules are repeated after 8 h, if three forceful contractions are not obtained during 10 min.
- Induction will be initiated with a dose of 2 mIu/min and increased by 2 mIu/min every 15 min until three forceful contractions be obtained for 10 min, or to a maximum dose of 30 mIu/min. Then, continue at this rate for 8 h. If patients entered the active phase of labor (cervical dilatation = 3-4 cm), induction continue until delivery.
- Amniotomy is performed when cervical dilation reached 5 cm, if the membrane has not been ruptured spontaneously.
- The partogram will be used to monitor the fetal heart rate, membrane status, cervical dilation and effacement, station of the fetus, uterine contractions, maternal pulse, maternal blood pressure, maternal temperature.
- If there is no response to induction on the second day, a cesarean section will be performed.
- The participants are followed up until delivery.
Safety Considerations:
If the parturient has hyperstimulation of contractions (in a situation with more than 5 contractions/10 min, duration of contraction > 90 sec, interval of contraction less than 2 min, or fetal distress), the induction will be stopped, and the parturient is kept in left lateral position and given oxygen, and intravenous dextrose.
- Conditions
- Poor; Labor
- Being tested
- propranolol, placebo, Oxytocin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propranololDrug
Also called indral
propranolol 20 mg given before induction of labor
placeboDrug
starch tablet containing no active drug material given before induction of labor
OxytocinDrug
Also called syntocinon
intravenous infusion of oxytocin
| Study group | Role | What they receive |
|---|---|---|
| propranolol plus oxytocin | Active comparator | 121 patients who will receive a capsule containing 20 mg propranolol (propranolol plus oxytocin) administrated orally before beginning induction and repeated after 8 hours if no sufficient uterine contractions reached. Receives: Drug: propranolol; Drug: Oxytocin |
| placebo plus oxytocin | Placebo comparator | 121 control patients who will receive a similar capsule as a placebo (oxytocin plus placebo) before beginning induction. Receives: Drug: placebo; Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of first stage of labour
duration of first stage of labour in hours
Measured: 24 hours
Secondary outcomes (2)
rate of cesarean section
number of participants eventually undergo cesarean section
Measured: 48 hours
Apgar score
Apgar score at minute 1 and minute 5 following delivery
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 posted9 Mar 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor; LaborStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Ahmed Mahmoud Riad, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702674
- Sponsor's protocol ID
- propranolol
- Status last verified
- Mar 2016
- First submitted
- 13 Feb 2016
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Coadministration of Oral Propranolol to Oxytocin on Induction of Labor
- ClinicalTrials.gov ID
- NCT02702674
- Acronym / sponsor ID
- propranolol
- Conditions
- Poor; Labor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 9 Mar 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.
The effect of coadministration of oral propranolol to oxytocin on induction of labor.
Detailed description
Study hypothesis:
Oral propranolol when used with oxytocin during the process of labor may reduce labor interval and decrease the rate of cesarean delivery.
Study population:
The patients will be recruited from the women attending obstetrics reception room, in Ain Shams University Maternity Hospital.
Intervention:
After taking informed consent, all patients recruited in the study will undergo complete clinical examination and detailed medical history will be obtained along with necessary laboratory investigations and ultrasound. Each patient will have a case record form in which the following data will be recorded:
- History: personal (age, duration of marriage), present illness (any current medical or surgical diseases and any current medication), obstetric history (including parity, gestational age, obstetric complications) and past medical history(especially cardiac problems).
- Clinical examination:
- General examination: assessment of vital data, cardiac and chest auscultation to exclude contraindications for drug administration.
- Abdominal examination: assessment of fundal level and contractions if present.
- Pelvic examination: assessment of Bishop score, membrane status and fetal presentation.
- Investigations:
- Routine investigations will be done e.g., Full blood count, CRP titre.
- Pelvi-abdominal U/S (confirm fetal life, placental location, fetus parameters, amniotic fluid index, expected fetal weight).
Steps:
- Informed consent will be obtained from parents or guardians of patients who are invited to participate in the research after explanation of benefits and risks of this trial.
- A capsule containing 20 mg propranolol to the first group (propranolol plus oxytocin) and a similar capsule as a placebo to the second group (oxytocin plus placebo) are administrated orally before beginning induction. Oral capsules are repeated after 8 h, if three forceful contractions are not obtained during 10 min.
- Induction will be initiated with a dose of 2 mIu/min and increased by 2 mIu/min every 15 min until three forceful contractions be obtained for 10 min, or to a maximum dose of 30 mIu/min. Then, continue at this rate for 8 h. If patients entered the active phase of labor (cervical dilatation = 3-4 cm), induction continue until delivery.
- Amniotomy is performed when cervical dilation reached 5 cm, if the membrane has not been ruptured spontaneously.
- The partogram will be used to monitor the fetal heart rate, membrane status, cervical dilation and effacement, station of the fetus, uterine contractions, maternal pulse, maternal blood pressure, maternal temperature.
- If there is no response to induction on the second day, a cesarean section will be performed.
- The participants are followed up until delivery.
Safety Considerations:
If the parturient has hyperstimulation of contractions (in a situation with more than 5 contractions/10 min, duration of contraction > 90 sec, interval of contraction less than 2 min, or fetal distress), the induction will be stopped, and the parturient is kept in left lateral position and given oxygen, and intravenous dextrose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propranolol plus oxytocin | Active comparator | Drug: propranolol, Drug: Oxytocin121 patients who will receive a capsule containing 20 mg propranolol (propranolol plus oxytocin) administrated orally before beginning induction and repeated after 8 hours if no sufficient uterine contractions reached. |
| placebo plus oxytocin | Placebo comparator | Drug: placebo, Drug: Oxytocin121 control patients who will receive a similar capsule as a placebo (oxytocin plus placebo) before beginning induction. |
Who may qualify
- Ages
- 17 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Gestational age above 37 weeks.
- Fetal life positive on ultrasound.
- Bishop score > 5.
- Primiparous women.
Key exclusion criteria (7 listed)
- history of uterine surgery
- polyhydramnios
- contraindications to β-adrenergic agents, such as systolic blood pressure less than 100 mmHg or pulse rate less than 60/min and more than 120/min
- history of any known cardiac disease
- mother's pulmonary or metabolic disorders
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 |
|---|---|---|
| propranololAlso: indralpropranolol 20 mg given before induction of labor | Drug | propranolol plus oxytocin |
| placebostarch tablet containing no active drug material given before induction of labor | Drug | placebo plus oxytocin |
| OxytocinAlso: syntocinonintravenous infusion of oxytocin | Drug | placebo plus oxytocin, propranolol plus oxytocin |
Primary outcome
duration of first stage of labour
Time frame: 24 hours
duration of first stage of labour in hours
2 secondary outcomes
rate of cesarean section
Time frame: 48 hours
Apgar score
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing propranolol and Oxytocin in people with Poor; Labor, run by Ain Shams Maternity Hospital 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 9 Mar 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr A Riad, MD (01005347179 ext. +2, amr.riad@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of 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 9 Mar 2016; AzTrials last refreshed its copy on 8 Nov 2026.