Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02702674 |
| Other study ID # |
propranolol |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 3
|
| First received |
February 13, 2016 |
| Last updated |
March 3, 2016 |
| Start date |
December 2015 |
| Est. completion date |
December 2016 |
Study information
| Verified date |
March 2016 |
| Source |
Ain Shams Maternity Hospital |
| Contact |
Amr A Riad, MD |
| Phone |
01005347179 |
| Email |
amr.riad[@]med.asu.edu.eg |
| Is FDA regulated |
No |
| Health authority |
Egypt: Ministry of Health and Population |
| Study type |
Interventional
|
Clinical Trial Summary
The effect of coadministration of oral propranolol to oxytocin on induction of labor.
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.
