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Fetal Reduction: Mechanical vs Chemical

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ClinicalTrials.gov Identifier: NCT03473158
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
Riyadh Fertility and Reproductive Health center
Information provided by (Responsible Party):
Ahmed AA Wali, MD, Cairo University

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.

Condition or disease Intervention/treatment Phase
Multiple Pregnancy Device: Transvaginal ultrasound Procedure: Mechanical fetal reduction Procedure: Chemical fetal reduction Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Fetal Reduction Through a Transvaginal Ultrasound Guided Approach in Multifetal Pregnancies: Mechanical Disruption Against Potassium Chloride Injection. A Randomized Controlled Trial
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arm Intervention/treatment
Active Comparator: 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
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)
Other Name: Mechanical disruption

Active Comparator: 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
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: 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)
Other Name: Potassium Chloride




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03473158


Contacts
Contact: Ahmed AA Wali, MD 01001735088 ext +2 ahmed.wali@kasralainy.edu.eg

Locations
Egypt
Cairo University Recruiting
Cairo, Egypt, 11562
Contact: Ahmed AA Wali, MD    01001735088 ext +2    ahmed.wali@kasralainy.edu.eg   
Principal Investigator: Hassan Omar, MD         
Principal Investigator: Ahmed M Maged, MD         
Principal Investigator: Ahmed AA Wali, MD         
Sub-Investigator: Shimaa Mostafa, MD         
Sub-Investigator: Mohamed F Nour, Msc         
Sponsors and Collaborators
Cairo University
Riyadh Fertility and Reproductive Health center
Investigators
Study Director: Hassan Omar, MD Cairo University

Responsible Party: Ahmed AA Wali, MD, Lecturer of Obstetrics and Gynecology, Cairo University
ClinicalTrials.gov Identifier: NCT03473158     History of Changes
Other Study ID Numbers: IVF-001-2018
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ahmed AA Wali, MD, Cairo University:
fetal reduction
embryo reduction
feticide
potassium chloride
multiple pregnancy
multifetal pregnancy