Clinical trial NCT03473158: Fetal Reduction: Mechanical vs Chemical
Official title: Early Fetal Reduction Through a Transvaginal Ultrasound Guided Approach in Multifetal Pregnancies: Mechanical Disruption Against Potassium Chloride Injection. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Pregnancy
Keywords: fetal reduction
embryo reduction
feticide
potassium chloride
multiple pregnancy
multifetal pregnancy
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Riyadh Fertility and Reproductive Health center
First posted: 2018-03-22
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Success of the procedure
timeFrame: 5 minutes after the end of fetal reduction
Secondary outcomes:
measure: Duration of the fetal reduction procedure
timeFrame: 5 minutes after the end of the procedure when cessation of fetal heart is confirmed
measure: Post-operative vaginal spotting or bleeding
timeFrame: within the first week of the procedure i.e. from the end of the procedure till 7 days after the procedure
measure: Gestational age at birth
timeFrame: On the same day of delivery
measure: Fetal birth weight
timeFrame: On the same day of delivery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Hassan Omar, MD
role: STUDY_DIRECTOR
References: