Outcomes in Spontaneous and ART Twin Pregnancies

Maternal and Perinatal Outcomes in Spontaneous Twins Versus Twins Conceived by Ovulation Induction and Assisted Reproductive Techniques: A Cross Section Study Within One Year

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

Study Overview

• Status: Completed
• Conditions: Maternal Morbidity; Neonatal SEPSIS; Perinatal Mortality

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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Iraq
  • Kurdistan Region
    • Erbil, Kurdistan Region, Iraq, 44001
      • Kurdistan Board for Medical speciality

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Twin delivery was identified when coming to outpatient clinic & labour ward into two groups, first group iatrogenic conceived twins (either ART, or medical ovulation induction mainly clomiphene citrate and gonadotrophins).The second group is a twin pregnancy who conceived naturally .

Demographic characters, maternal and neonatal outcomes were compared in both groups

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal diabetes using glucose tolerance test	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	up to 7 days postpartum
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	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)	up to 1 week postpartum
Maternal anemia using WHO criteria	Hemoglobin level less than 11gm/dl	up to 1 week
Postpartum hemorrhage	Bleeding from genital tract of 500 mL or more vaginally	up to 1 week
Neonatal weight in kilogram	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	up to 7 days
Neonatal Apgar(Appearance, Pulse, Grimace, Activity, and Respiration) score	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>	first and fifth minute of life
Admission to neonatal care unit in days	Fetal care unit	up to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal mode of delivery	Cesarean section or vaginal delivery	during labor

Collaborators and Investigators

• Sponsor: Hawler Medical University
• Investigators: Principal Investigator: Diana Y. Rashid, Maternity Teaching Hospital; Study Director: Shahla K. Alalaf, Hawler Medical University, College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: June 16, 2018
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (Actual): July 18, 2018

Study Record Updates

• Last Update Posted (Actual): July 23, 2018
• Last Update Submitted That Met QC Criteria: July 20, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Perinatal mortality; ART; Twins; Induction of Ovulation
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Sepsis; Pregnancy Complications; Death; Perinatal Death; Neonatal Sepsis
• Other Study ID Numbers: SAlalaf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No