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Completed

NCT Number: NCT03473158

Fetal Reduction: Mechanical vs Chemical

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 11562, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transvaginal ultrasound

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

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)

Other names: Mechanical disruption

Chemical fetal reduction

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)

Other names: Potassium Chloride

Primary outcomes

  1. Success of the procedure

    Time frame: 5 minutes after the end of fetal reduction

    Number of gestational sacs in which fetal heart activity will stop

Secondary outcomes

  1. Duration of the fetal reduction procedure

    Time frame: 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)

  2. Post-operative vaginal spotting or bleeding

    Time frame: 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

  3. Gestational age at birth

    Time frame: On the same day of delivery

    age of pregnancy in weeks and days at time of delivery

  4. Fetal birth weight

    Time frame: On the same day of delivery

    fetal weight in grams at time of delivery

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Riyadh Fertility and Reproductive Health center

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 22, 2018
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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