Fetal Reduction: Mechanical vs Chemical

Study Overview
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Brief Summary
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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
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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.

Official Title
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Early Fetal Reduction Through a Transvaginal Ultrasound Guided Approach in Multifetal Pregnancies: Mechanical Disruption Against Potassium Chloride Injection. A Randomized Controlled Trial

Conditions
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Multiple Pregnancy

Intervention / Treatment
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* Device: Transvaginal ultrasound
* Procedure: Mechanical fetal reduction
* Procedure: Chemical fetal reduction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women with multifetal pregnancy (3 fetuses or more) Pregnant women from 6 weeks to 9 weeks + 6 days Exclusion Criteria: Pregnant women with singleton or twin pregnancy Pregnant women before 6 weeks (higher incidence of spontaneous vanishing twin) Pregnant women after 9 weeks + 6 days (the technique is difficult to apply) Pelvic or genital infection Hemorrhagic blood disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mechanical<br>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 | Device: Transvaginal ultrasound<br>* using the 6.5mHz intra-cavitary probe (65EC10EA) of ultrasound machine DP-50 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., P.R.China) to determine the number, site, size and cardiac activity of the fetuses, and monitor the fetal reduction procedure<br>Procedure: Mechanical fetal reduction<br>* under transvaginal ultrasound guidance, 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 (Cook® Ireland Ltd., Limerick, Ireland)<br>* Other names: Mechanical disruption;|
| Active Comparator: Chemical<br>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 | Device: Transvaginal ultrasound<br>* using the 6.5mHz intra-cavitary probe (65EC10EA) of ultrasound machine DP-50 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., P.R.China) to determine the number, site, size and cardiac activity of the fetuses, and monitor the fetal reduction procedure<br>Procedure: Chemical fetal reduction<br>* under transvaginal ultrasound guidance, 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 (Cook® Ireland Ltd., Limerick, Ireland)<br>* Other names: Potassium Chloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of the procedure | Number of gestational sacs in which fetal heart activity will stop | 5 minutes after the end of fetal reduction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the fetal reduction procedure | 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) | 5 minutes after the end of the procedure when cessation of fetal heart is confirmed | 
| Post-operative vaginal spotting or bleeding | Number of participants who will develop vaginal spotting or bleeding related to the procedure | within the first week of the procedure i.e. from the end of the procedure till 7 days after the procedure | 
| Gestational age at birth | age of pregnancy in weeks and days at time of delivery | On the same day of delivery | 
| Fetal birth weight | fetal weight in grams at time of delivery | On the same day of delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fetal reduction, embryo reduction, feticide, potassium chloride, multiple pregnancy, multifetal pregnancy