Fetal Reduction: Mechanical vs Chemical

Multiple Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03473158
• Other study ID #: IVF-001-2018
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: October 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Pregnancy

Intervention

Device:
• 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

Procedure:
• 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)
• 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)

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Cairo University	Riyadh Fertility and Reproductive Health center

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of the procedure	Number of gestational sacs in which fetal heart activity will stop	5 minutes after the end of fetal reduction
Secondary	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
Secondary	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
Secondary	Gestational age at birth	age of pregnancy in weeks and days at time of delivery	On the same day of delivery
Secondary	Fetal birth weight	fetal weight in grams at time of delivery	On the same day of delivery