Outcomes in Spontaneous and ART Twin Pregnancies

NCT03590483 | Completed

• 1 other identifier: SAlalaf
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Neonatal SEPSIS; Perinatal Mortality; Maternal Morbidity

Keywords

Twins; ART; Induction of Ovulation; Perinatal mortality

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Maternal mode of delivery

  during labor

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hawler Medical University: lead

Study Sites (1)

Kurdistan Board for Medical speciality

Erbil, Kurdistan Region, 44001, Iraq

Location

MeSH Terms

Conditions

Neonatal Sepsis; Perinatal Death

Condition Hierarchy (Ancestors)

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

Study Officials

• Diana Y. Rashid

  Maternity Teaching Hospital

  PRINCIPAL INVESTIGATOR

• Shahla K. Alalaf

  Hawler Medical University, College of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 16, 2018
• First Posted: July 18, 2018
• Study Start: November 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: July 23, 2018

Record last verified: 2018-07

Locations

IR (1)