Clinical trial NCT03590483: Outcomes in Spontaneous and ART Twin Pregnancies
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal SEPSIS
Perinatal Mortality
Maternal Morbidity
Keywords: Twins
ART
Induction of Ovulation
Perinatal mortality
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2018-07-18
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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

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

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Maternal diabetes using glucose tolerance test
timeFrame: up to 7 days postpartum
measure: 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
timeFrame: up to 1 week postpartum
measure: Maternal anemia using WHO criteria
timeFrame: up to 1 week
measure: Postpartum hemorrhage
timeFrame: up to 1 week
measure: Neonatal weight in kilogram
timeFrame: up to 7 days
measure: Neonatal Apgar(Appearance, Pulse, Grimace, Activity, and Respiration) score
timeFrame: first and fifth minute of life
measure: Admission to neonatal care unit in days
timeFrame: up to 7 days
Secondary outcomes:
measure: Maternal mode of delivery
timeFrame: during labor
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Kurdistan Board for Medical speciality
state: Kurdistan Region
Study officials:
affiliation: Maternity Teaching Hospital
name: Diana Y. Rashid
role: PRINCIPAL_INVESTIGATOR
affiliation: Hawler Medical University, College of Medicine
name: Shahla K. Alalaf
role: STUDY_DIRECTOR
References: