Induction of Labor Affected Fetus / Newborn Clinical Trial
Official title:
Dexamethasone Effect on Induction Delivery Interval at Term Randomized Controlled Trial
This study aims to evaluate the effect of intravenous injection of a single dose of dexamethasone in shortening the duration interval between initiation of labor induction and delivery of the fetus in primigravida full-term pregnancy.
Research hypothesis:
In full term primigravidae undergoing induction of labor, the use of a single dose of
dexamethasone (8mg) intra-venously will help in shortening the duration interval between
initiation of labor induction and delivery of the fetus.
Research question:
In full term primigravidae undergoing induction of labor, does the use of intra-venous
dexamethasone play a role in shortening the duration interval between initiation of labor
induction and delivery of the fetus?
Patients and Methods
Type of study:
Double blind randomized controlled trial.
Study settings:
Site: Ain Shams Maternity Hospital Study duration: 6 months
Study population:
One hundred and two pregnant women will be recruited in this study from women attending the
emergency room department of obstetrics and gynecology at Ain Shams University.
Inclusion criteria:
Primiparity Singleton pregnancy Gestational age i.e. 40 weeks or more by date or 1st
trimestric ultrasound. Bishop score of 4 or greater. Longitudinal lie. Vertex presentation.
Intact membranes
Exclusion criteria:
Refused consent Malpresentation. Multiple pregnancies. Active phase of labour. Rupture of
membranes (ROM). Cephalo-pelvic disproportion. Previous C-section or myomectomy operation.
Known contraindication or hypersensitivity to Dexamethasone. Fetal distress. IUFD Current
maternal disorder e.g. diabetes mellitus and pregnancy induced hypertension.
Over distended abdomen e.g. fetal macrosomia or polyhydramonus suggested by ultrasound.
Ante-partum hemorrhage e.g. placenta previa, accidental hemorrhage.
These criteria will be assessed at first during the initial evaluation in the delivery suite
as follows:
History:
Personal, menstrual, obstetric, past and family history will be taken. History of present
pregnancy will be taken including the first day of last menstrual period, duration of
pregnancy, warning symptoms as headache, visual symptoms, edema of face and fingers,
excessive vomiting, heart burn, epigastric pain, vaginal bleeding, decreased fetal movements,
edema of the lower limbs and history of any drug intake.
Examination:
1. General examination:vital signs, chest, heart and lower limb examination.
2. Abdominal examination: for assessment of fundal level, presentation, expected fetal
weight, fetal heart rate and presence of scars of previous operations as cesarean
section or myomectomy.
3. Vaginal examination: for assessment of cervical dilatation and effacement at the
beginning, state of fetal membranes, station of fetal head, position of fetal head and
pelvic adequacy.
Investigations:
1. Laboratory: blood grouping, Rh typing, complete blood count.
2. Abdominal ultrasound: to confirm the gestational age, fetal number, viability,
presentation, position, estimated fetal weight, and to detect the grade of placental
maturity, amount and turbidity of liquor.
3. CTG: application of CTG half an hour to all participates before starting any
intervention.
Enrollment and Allocation of the patients:
After approval of health ethical committee in Ain Shams Hospital and after the initial
evaluation, women who fulfilled the appropriate inclusion and exclusion criteria will be
invited to participate in the study, a verbal consent will be obtained from each candidate
after explanation of the procedure in details.
Randomization:
The eligible 102 women will be randomized into one of the following two groups:
1. Group D (study group): including 51 women who will receive a prefilled syringe with two
milliliters (8 mg) of dexamethasone intravenously.
2. Group P (control group): including 51 women who will receive a prefilled syringe with
two milliliters of distilled water intravenously.
No cervical ripping agent will be used for induction of labor in either group. Randomization
is performed using a computer-generated randomization system. 102 opaque envelopes will be
numbered serially; each envelope will contain the corresponding letter in the randomization
table, and when the first pregnant woman arrived, the first envelope will be opened and the
pregnant woman will be allocated to the group according to the inside letter.
;
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