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

The effect of coadministration of oral propranolol to oxytocin on induction of labor.

Study Overview

• Status: Unknown
• Conditions: Poor; Labor
• Intervention / Treatment: Drug: propranolol; Drug: Oxytocin; Drug: placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 242
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ain Shams Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 40 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Drug: propranolol; propranolol 20 mg given before induction of labor; Other Names: indral; Drug: Oxytocin; intravenous infusion of oxytocin; Other Names: syntocinon
PLACEBO_COMPARATOR: placebo plus oxytocin; 121 control patients who will receive a similar capsule as a placebo (oxytocin plus placebo) before beginning induction.	Drug: Oxytocin; intravenous infusion of oxytocin; Other Names: syntocinon; Drug: placebo; starch tablet containing no active drug material given before induction of labor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of first stage of labour	duration of first stage of labour in hours	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of cesarean section	number of participants eventually undergo cesarean section	48 hours
Apgar score	Apgar score at minute 1 and minute 5 following delivery	24 hours

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (ANTICIPATED): December 1, 2016
• Study Completion (ANTICIPATED): December 1, 2016

Study Registration Dates

• First Submitted: February 13, 2016
• First Submitted That Met QC Criteria: March 3, 2016
• First Posted (ESTIMATE): March 9, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): March 9, 2016
• Last Update Submitted That Met QC Criteria: March 3, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Reproductive Control Agents; Oxytocics; Propranolol; Oxytocin
• Other Study ID Numbers: propranolol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED