Outcomes in Spontaneous and ART Twin Pregnancies

Neonatal SEPSIS Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03590483
• Other study ID #: SAlalaf
• Status: Completed
• Start date: November 1, 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: July 2018
• Source: Hawler Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Maternal Morbidity
• Neonatal SEPSIS
• Perinatal Death
• Perinatal Mortality

Locations

Country	Name	City	State
Iraq	Kurdistan Board for Medical speciality	Erbil	Kurdistan Region

Sponsors (1)

Lead Sponsor	Collaborator
Hawler Medical University

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Maternal anemia using WHO criteria	Hemoglobin level less than 11gm/dl	up to 1 week
Primary	Postpartum hemorrhage	Bleeding from genital tract of 500 mL or more vaginally	up to 1 week
Primary	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
Primary	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
Primary	Admission to neonatal care unit in days	Fetal care unit	up to 7 days
Secondary	Maternal mode of delivery	Cesarean section or vaginal delivery	during labor