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Completed

NCT Number: NCT03590483

Outcomes in Spontaneous and ART Twin Pregnancies

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

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Key information

Conditions

Neonatal SEPSIS Congenital, Hereditary, and Neonatal Diseases and Abnormalities Death Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infections Inflammation Maternal Morbidity Pathologic Processes Pathological Conditions, Signs and Symptoms Perinatal Death Perinatal Mortality Pregnancy Complications Sepsis Systemic Inflammatory Response Syndrome Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Kurdistan Board for Medical speciality

Erbil, Kurdistan Region, 44001, Iraq

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  2. 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)

  3. Maternal anemia using WHO criteria

    Time frame: up to 1 week

    Hemoglobin level less than 11gm/dl

  4. Postpartum hemorrhage

    Time frame: up to 1 week

    Bleeding from genital tract of 500 mL or more vaginally

  5. 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

  6. 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>

  7. Admission to neonatal care unit in days

    Time frame: up to 7 days

    Fetal care unit

Secondary outcomes

  1. Maternal mode of delivery

    Time frame: during labor

    Cesarean section or vaginal delivery

Sponsors and collaborators

Lead sponsor

Hawler Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 18, 2018
Registry last updated
Jul 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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