Fetal Reduction: Mechanical vs Chemical

NCT ID: NCT03473158

Last Updated: 2020-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2019-03-31

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.

Conditions

Multiple Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Mechanical

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

Group Type: ACTIVE_COMPARATOR

Transvaginal ultrasound

Intervention Type: DEVICE

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

Mechanical fetal reduction

Intervention Type: PROCEDURE

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)

Chemical

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

Group Type: ACTIVE_COMPARATOR

Transvaginal ultrasound

Intervention Type: DEVICE

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

Chemical fetal reduction

Intervention Type: PROCEDURE

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)

Interventions

Transvaginal ultrasound

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

Intervention Type: DEVICE

Mechanical fetal reduction

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)

Intervention Type: PROCEDURE

Chemical fetal reduction

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)

Intervention Type: PROCEDURE

Other Intervention Names

Mechanical disruption; Potassium Chloride

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Riyadh Fertility and Reproductive Health center

OTHER

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed AA Wali, MD

Lecturer of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hassan Omar, MD

Role: STUDY_DIRECTOR

Cairo University

Locations

Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

IVF-001-2018

Identifier Type: -

Identifier Source: org_study_id