Multiple Pregnancy
Conditions
Keywords
fetal reduction, embryo reduction, feticide, potassium chloride, multiple pregnancy, multifetal pregnancy
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.
Interventions
DEVICETransvaginal 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
PROCEDUREMechanical 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)
PROCEDUREChemical 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)
Sponsors
Riyadh Fertility and Reproductive Health center
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success of the procedure | 5 minutes after the end of fetal reduction | Number of gestational sacs in which fetal heart activity will stop |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of the fetal reduction procedure | 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) |
| Post-operative vaginal spotting or bleeding | 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 |
| Gestational age at birth | On the same day of delivery | age of pregnancy in weeks and days at time of delivery |
| Fetal birth weight | On the same day of delivery | fetal weight in grams at time of delivery |
Countries
Egypt
Outcome results
None listed