The Effect of Coadministration of Oral Propranolol to Oxytocin on Induction of Labor

NCT ID: NCT02702674

Last Updated: 2016-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-12-31

Brief Summary

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:

1. 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).

2. Clinical examination:

1. General examination: assessment of vital data, cardiac and chest auscultation to exclude contraindications for drug administration.

2. Abdominal examination: assessment of fundal level and contractions if present.

3. Pelvic examination: assessment of Bishop score, membrane status and fetal presentation.

3. Investigations:

1. Routine investigations will be done e.g., Full blood count, CRP titre.

2. Pelvi-abdominal U/S (confirm fetal life, placental location, fetus parameters, amniotic fluid index, expected fetal weight).

Steps:

1. 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.

2. 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.

3. 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.

4. Amniotomy is performed when cervical dilation reached 5 cm, if the membrane has not been ruptured spontaneously.

5. 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.

6. If there is no response to induction on the second day, a cesarean section will be performed.

7. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

propranolol plus oxytocin

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.

Group Type: ACTIVE_COMPARATOR

propranolol

Intervention Type: DRUG

propranolol 20 mg given before induction of labor

Oxytocin

Intervention Type: DRUG

intravenous infusion of oxytocin

placebo plus oxytocin

121 control patients who will receive a similar capsule as a placebo (oxytocin plus placebo) before beginning induction.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

starch tablet containing no active drug material given before induction of labor

Oxytocin

Intervention Type: DRUG

intravenous infusion of oxytocin

Interventions

propranolol

propranolol 20 mg given before induction of labor

Intervention Type: DRUG

placebo

starch tablet containing no active drug material given before induction of labor

Intervention Type: DRUG

Oxytocin

intravenous infusion of oxytocin

Intervention Type: DRUG

Other Intervention Names

indral; syntocinon

Eligibility Criteria

Inclusion Criteria

1. Gestational age above 37 weeks.

2. Fetal life positive on ultrasound.

3. Bishop score > 5.

4. Primiparous women.

Exclusion Criteria

1. history of uterine surgery

2. polyhydramnios

3. 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

4. history of any known cardiac disease

5. mother's pulmonary or metabolic disorders

6. fetal distress

7. estimated weight of the fetus more than 4 kg by ultrasound of cephalic presentation

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams Maternity Hospital

OTHER

Sponsor Role: lead

Responsible Party

Amr Ahmed Mahmoud Riad

Lecturer of obstetrics and gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams maternity hospital

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Amr A Riad, MD

Role: CONTACT

amr.riad@med.asu.edu.eg

01005347179 ext. +2

Other Identifiers

propranolol

Identifier Type: -

Identifier Source: org_study_id