Efficacy and Feto Maternal Outcome of Induction of Labor with Mifepristone and Intracervical Dinoprostone Gel Versus Intracervical Dinoprostone Gel alone in Term Pregnancy A Double Blind Randomized Control Trial

Ante-natal women who are full filling inclusion criteria and have valid indications of induction of labour like postdated   pregnancy, Premature rupture of membranes, pregnancy induced hypertension, gestational diabetes mellitus, oligohydramnios, Intrauterine growth restriction etc. will be included in the study

INCLUSION CRITERIA:Valid indications for induction of labour like postdated pregnancy, Premature rupture of membranes, pregnancy induced hypertension, gestational diabetes mellitus, oligohydramnios, Intra uterine growth restriction etc. are included in the study.

1. Maternal age ≥ 18 years

2. Term pregnancy ≥37 weeks

3. Singleton pregnancy

4. Cephalic presentation

5. Live fetus

6. Reactive Non-Stress Test

6)Modified Bishop’s score <6

 EXCLUSION CRITERIA:  Women with any contraindication to induction and vaginal delivery

Incomplete data

Estimated fetal weight ≥ 4.5 kg or ≤ 2.0 kg

Antepartum Hemorrhage (Abruption Placenta, Placenta Previa)

Previous caesarean sections

Abnormal Doppler studies and Non stress test.

Severe Oligohydramnios [AFI< 5]

Chorioamnionitis

Major Cephalopelvic disproportion

Parity > 4

Patients requiring immediate delivery

Severe pre-eclampsia, eclampsia

Intrauterine death

Heart disease complicating pregnancy

 **METHODS:**After Ascertaining inclusion and exclusion criteria and obtaining written and informed consent 220 women will be enrolled in the study 110 in each group. Detailed history of all the patients taken according to the proforma and complete clinical examination and necessary investigations are done.

Women will be randomized into two groups according to computer generated randomized table. The number of participants in study group will be 110 and control group will be 110.

PI will give the participants the drug packet according to computer generated randomized numbers and drug packet number is noted in proforma.

Study will be double blinded, both participant and PI will be blinded

At the end of study, proforma number will be tallied with computer generated table , if it is placebo or the drug.

Pre-induction Bishop score will be noted.

Women randomized to study group will receive one tablet Mifepristone 200 mg per oral at the moment of enrollment. The participants in control group will receive placebo and bishop score noted for two groups.

After 24 hours, both groups will receive dinoprostone gel 0.5 mg after 6 hours Bishop’s score will be checked again, intracervical dinoprostone gel repeated 6 hourly for total of 3 doses if bishop score <8

Before each dose of dinoprostone gel fetal wellbeing will be evaluated by clinical examination and Cardiotocography.

Augmentation with oxytocin will be done when warranted.

If with 3 doses of dinoprostone gel the bishops score not improved then the induction will be categorized as failed induction.

When the women entered in active labor, augmentation of labor will be done by using Oxytocin drip, but not earlier than 6 hours from last dose of intracervical dinoprostone gel application.

Induction to delivery interval will be noted in both the groups.

Mode of delivery will be noted

Maternal and neonatal outcome/ complications will be noted

Purpose of the study

Induction of labor is an obstetric procedure, it is designed to pre attempt the natural process of labor by initiating its onset artificially, before labor occurs spontaneously. When continuation of pregnancy presents a threat to the life or well-being of the mother or unborn child. The infant should be delivered in a good condition, in an acceptable time frame and with minimal maternal discomfort or side effects. The aim of successful induction is to achieve vaginal delivery

Induction of labor has two important components, cervical ripening and stimulation of uterine contractions to achieve dilation of cervix and delivery of the fetus. It is well recognized that the success of induction of labor, which ultimately aims at achieving vaginal delivery, depends to a great extent on the favorability of the cervix or its readiness to go into labor. Agents used for cervical ripening may lead in the establishment of contractions to women with unfavorable cervix. Pharmacological methods like Prostaglandins (PGE1, PGE2) and mechanical methods like Hygroscopic cervical dilators, membrane stripping, trans cervical catheter, etc. are available for pre induction cervical ripening.

Mifepristone, an antiprogesterone is a receptor level antagonist. Mifepristone ,19-norsteroid has great affinity for the progesterone receptor and thus blocks the action of progesterone at cellular level and its smooth muscle relaxing effect and increasing the sensitivity of the uterus to the action of prostaglandins.

Present study is being done to evaluate the efficacy of addition of mifepristone with dinoprostone gel in induction of labour with the outcome of induction and fetomaternal effects