Outcomes in Spontaneous and ART Twin Pregnancies

Overview

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

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: December 31, 2017

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 .

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Maternal mode of delivery
    • Time Frame: during labor
    • Cesarean section or vaginal delivery

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hawler Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shahla Alalaf, professor – Hawler Medical University
  • Overall Official(s)
    • Diana Y. Rashid, Principal Investigator, Maternity Teaching Hospital
    • Shahla K. Alalaf, Study Director, Hawler Medical University, College of Medicine

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.