Medical Induction of Labor Affecting Fetus Clinical Trial
Official title:
Effect Of Intra-muscular Administration of Dexamethasone on the Duration of Induction of Labour in Primigravida Post-term Pregnancy.
ABSTRACT:
Objective: To evaluate the efficacy of dexamethasone on labor duration and to establish
whether dexamethasone plays a role in shorting the duration interval between initiation of
labor induction and beginning of the active phase in primigravida full-term pregnancy.
Methods: case control study included 86 primigravidae with full term pregnancy classified
into two groups: The participant of Group I will receive a prefilled syringe with two
milliliters (8 mg) of Dexamethasone intramuscular, and the participants of Group II will not
receive Dexamethasone or any other cervical ripening agent.
Key Words: Dexamethasone;post-term pregnancy;induction of labor.
METHODS:
This retrospective clinical trial was conducted at the Department of Obstetrics and
Gynecology, Faculty of Medicine, Cairo University, during the period from August 2014 to May
2015. The study protocol was approved by the Scientific Research Committee, and informed
consent was obtained from all participants.
Each participant will randomly be assigned by computer list into Group I (Dexamethasone
group(n=43)and group II(control group(N=43).
No cervical ripening agent will be used for induction of labour in the trial.
Methodology in details:
I. The participant of Dexamethasone Group will receive a prefilled syringe with two
milliliters (8 mg) of Dexamethasone intramuscular, and the participants of placebo Group
will not receive Dexamethasone or any other cervical ripening agent.
All the participants in both groups will randomly be assigned by computer list. (Haijavandi
et., al 2013)
II. After six hours of the initial dose, the labour induction will start via Oxytocin using
the following protocol:
1. Initial dose of oxytocin.................................. 1 to 2 milliliter
international unit/min.
2. Increase interval......................................................30 minutes.
3. Dosage increment....................................................1 to 2 milliliter
international unit/min.
4. Usual dose for good labour.........................8 to12 milliliter international
unit/min.
5. Maximum dose…………………...................30 milliliter international unit/min. (Anne
Biringer et., al 2013).
III. The interval between the initiation of induction and the beginning of the active phase
of labour is recorded (a cervical dilatation of 4 cm plus 3 forceful contractions over a
10-minute span each last from 40-60 Sec).
IV. Partographic representation for progression of active phase labour:
1. Frequency and duration of uterine contraction.
2. Cervical dilatation will record every two hours by per vaginal examination.
3. Station and position of fetal head was noted at the same time.
V. After delivery:-
1. The duration of the first stage of labor will be recorded. (Partographic representation
will do for each participant).
2. The duration of the second stage of labor will be recorded.
3. The duration of the placental separation will be recorded.
4. The neonatal outcome will be recorded by APGAR score.
5. Any postpartum maternal adverse effect was noted (e.g. vital sign abnormality, any
maternal postpartum hemorrhage).
Primary outcome:
the duration between induction and beginning of active phase.
Secondary outcome:
-Duration of first stage.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
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