Dexamethasone Effect on Induction of Labor Clinical Trial
Official title:
Role Of Dexamethasone In Induction Of Labor : A Randomized Clinical Trial .
Research hypothesis :
In pregnant women undergoing induction of labor, intramuscular injection of dexamethasone may
accelerate induction delivery interval.
Research question :
In pregnant women undergoing induction of labor, does intramuscular injection of
dexamethasone accelerate induction delivery interval ?
This study aims to assess the effect of intramuscular administration of dexamethasone on the
induction delivery interval in full term patients undergoing induction of labor.
The use of corticosteroids is one of the methods put forward for the strengthening and
speeding up the process of labor. After identification of glucocorticoid receptors in human
amnion, the role of corticosteroids in starting the process of labor has been studied in
numerous studies. Some of them discussed the relation between dexamethasone injection and
labor induction but still there is insufficient data. So by the end of this study it may be
possible to assess the effect of intramuscular dexamethasone injection on shortening the
induction delivery interval.
- Type of Study: Randomized Clinical Double Blind Trial .
- Study Setting: The study will be conducted at Ain Shams Maternity Hospital.
- Study Population: Full term patients who attend to the labor ward in El Demerdash
Maternity Hospital and scheduled for induction of labor.
- Sample Size: Sample size was calculated using PASS® version 15.0, setting the power (β)
at 0.02 and the significance level (α) at 0.05. Data from previous reports (Kashanian et
al., 2008) indicated that mean Induction-Active phase Interval in women receiving 8mg of
dexamethasone before induction of labor and controls was 3.09±1.5 and 4.21±1.8 hours
respectively. Calculation according to these values produced a minimal sample size of 70
patients to be randomized equally to both groups. Assuming a drop-out rate of 15%, a
minimum drop-out inflated enrollment sample size of approximately 80 women will be
needed.
- Ethical Considerations: The study will be approved from the Ethical Committee of the
Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University.
Informed written consent will be taken from all women before recruitment in the study,
and after extensive explanation and clear discussion of risks and benefits.
- Study Procedures: A total of 80 women undergoing induction of labor will be included in
this study after taking their consent for this clinical trial after full explanation of
the trial.
;