Fetal Reduction: Mechanical vs Chemical

Not Applicable

Completed

Interventions: Device: Transvaginal ultrasound
Procedure: Mechanical fetal reduction
Procedure: Chemical fetal reduction

Brief Summary: In this study multifetal pregnancy reduction (to twins) will be carried out through a transvaginal route, at an early gestational age (6 weeks - 9weeks + 6days) using 2 methods: mere mechanical disruption against potassium chloride injection. The 2 methods will be compared regarding the efficacy, complications and pregnancy outcome.

Detailed Description: The incidence of multifetal gestations has increased dramatically over the past several decades. Multiple pregnancies are frequently complicated by maternal and fetal morbidities and mortalities. Data show that the incidence of morbidity and mortality correlate with fetal number. In the United Kingdom, the single embryo transfer policy has reduced the incidence of multifetal gestation. Also, in the United States the ASRM (American society of reproductive medicine) has revised the guidelines to optimize the number of transferred embryos during IVF. However in Egypt, transfer of 3 to 4 embryos is still practiced. The procedure of fetal reduction aims to decrease the occurrence of maternal and perinatal morbidities related to multifetal gestations. It can be carried out transvaginally or transabdominally under ultrasound guidance. It may be done by potassium chloride injection through needle injection, mere mechanical disruption by a needle, or by radiofrequency ablation. In this study multifetal pregnancy reduction will be carried out through transvaginal route, at an early gestational age (6 weeks - 9weeks + 6days), and compare the efficacy, complications and pregnancy outcome using mere mechanical disruption against potassium chloride injection.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Mechanical	Mechanical fetal reduction	fetal reduction will be achieved by mechanical disruption of the fetal heart till asystole is achieved, and may be aided by partial or total suction of the fetus, using suction device attached to the embryo reduction needle
Mechanical	Transvaginal ultrasound	fetal reduction will be achieved by mechanical disruption of the fetal heart till asystole is achieved, and may be aided by partial or total suction of the fetus, using suction device attached to the embryo reduction needle
Chemical	Transvaginal ultrasound	fetal reduction will be achieved by injecting 0.5 mL of potassium chloride (Potassium Chloride® 15% , EIPICO, Egypt) into the cardiac region through the embryo reduction needle
Chemical	Chemical fetal reduction	fetal reduction will be achieved by injecting 0.5 mL of potassium chloride (Potassium Chloride® 15% , EIPICO, Egypt) into the cardiac region through the embryo reduction needle

Primary Outcome Measures

Name	Time	Method
Success of the procedure	5 minutes after the end of fetal reduction	Number of gestational sacs in which fetal heart activity will stop

Secondary Outcome Measures

Name	Time	Method
Fetal birth weight	On the same day of delivery	fetal weight in grams at time of delivery
Duration of the fetal reduction procedure	5 minutes after the end of the procedure when cessation of fetal heart is confirmed	Duration in minutes needed for each fetus to be reduced (from time of introduction of embryo reduction needle into the gestational sac till fetal heart activity stops)
Gestational age at birth	On the same day of delivery	age of pregnancy in weeks and days at time of delivery
Post-operative vaginal spotting or bleeding	within the first week of the procedure i.e. from the end of the procedure till 7 days after the procedure	Number of participants who will develop vaginal spotting or bleeding related to the procedure