Outcomes in Spontaneous and ART Twin Pregnancies

Completed

• Conditions: Maternal Morbidity; Neonatal SEPSIS; Perinatal Mortality

• Registration Number: NCT03590483
• Lead Sponsor: Hawler Medical University

Brief Summary

During the last decades, assisted reproductive technique has been transformed from a miracle to real and has become widely used for treatment human infertility.

this was associated with increased the rate of twin pregnancies

Detailed Description

Twin pregnancies are associated with an increased risk of maternal mortality \& morbidity and an increase in the incidence of neonatal morbidity and mortality compared to singleton pregnancy.

The heterogeneous results reported so far can also depend on differences in the studied populations and/or in the management approach to twin pregnancy, variability in data regarding neonatal and maternal outcomes.

Evidence on pregnancy outcomes of twins conceived by artificial reproductive technology (ART) compared with those naturally conceived (NC) is conflicting, A 2004 systematic review and a large 2008 study both were praised that in cases of twin pregnancy after assisted conception the perinatal mortality is significantly lower, when compared with those spontaneously conceived .

Study Timeline

• Study Start: 2016-11-01
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Study First Submitted: 2018-06-16
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-16
• Study First Posted: 2018-07-18
• Last Update Submitted: 2018-07-20
• Last Update Posted: 2018-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Twin delivered >24-week gestational age
• weight ≥ 500g
• Diachronic diamniotic twins.

Exclusion Criteria

• Intrauterine fetal deaths
• Higher-order multiple pregnancies
• Deliveries complicated by early vanishing fetuses
• Twin pregnancies reduced to singleton
• Triple pregnancy reduced to twin.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maternal diabetes using glucose tolerance test	up to 7 days postpartum	The diagnosis of GDM was based a fasting plasma glucose level of ≥5.6 mmol/L with 2 h plasma glucose level of ≥7.8 mmol/L
Admission to neonatal care unit in days	up to 7 days	Fetal care unit
Neonatal weight in kilogram	up to 7 days	categorized as extreme low birth weight (LBW) for \<1000 g, very LBW for 1000-1500 g, LBW for 1500-2500 g, and normal birth weight for \>2500 g
Maternal anemia using WHO criteria	up to 1 week	Hemoglobin level less than 11gm/dl
Hypertension during pregnancy and preeclampsia diagnosed using ACOG guideline a) weight in kilogram b) Apgar score in first and 10th minutes c)Admission to neonatal intensive acre unit measured in days	up to 1 week postpartum	Systolic and diastolic blood pressure equal or more than140/90 mm Hg measured on two or more occasions after 20 weeks of gestation in previously normotensive women, with or without proteinuria (proteinuria of \>100 mg/dL by urine analysis, or \>300 mg/24 h)
Postpartum hemorrhage	up to 1 week	Bleeding from genital tract of 500 mL or more vaginally
Neonatal Apgar(Appearance, Pulse, Grimace, Activity, and Respiration) score	first and fifth minute of life	Apgar scores includes 10 sores , 2 for each . The Apgar score was classified as severely depressed \<0-3\>, moderately depressed\<4-6\> and excellent condition\<7-10\>

Secondary Outcome Measures

Name	Time	Method
Maternal mode of delivery	during labor	Cesarean section or vaginal delivery

Trial Locations

Locations (1)

Kurdistan Board for Medical speciality; 🇮🇶 Erbil, Kurdistan Region, Iraq