Fetal Reduction: Mechanical vs Chemical

Cairo University (CU)

Status: Completed

Conditions: Multiple Pregnancy

Treatments: Procedure: Mechanical fetal reduction; Device: Transvaginal ultrasound; Procedure: Chemical fetal reduction

Study type: Interventional

Funder types: Other

Identifiers

NCT03473158

IVF-001-2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Mechanical

Active Comparator group

Description:

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

Treatment:

Procedure: Mechanical fetal reduction

Device: Transvaginal ultrasound

Chemical

Active Comparator group

Description:

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

Treatment:

Procedure: Chemical fetal reduction

Device: Transvaginal ultrasound