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Clinical Trials/NCT05104255
NCT05104255
Completed
Not Applicable

Factors Influencing the Neonatal Outcomes in Twin Pregnancies Undergoing Cesarean Section: a Cross-sectional Study

Derince Training and Research Hospital0 sites527 target enrollmentJanuary 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Twin Pregnancy
Sponsor
Derince Training and Research Hospital
Enrollment
527
Primary Endpoint
The Rate of Death
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Multiple pregnancies are associated with increased maternal and fetal risks compared to singleton pregnancies. Additionally, the cesarean section rate is quite high in multiple pregnancies. This study aimed to evaluate maternal and fetal characteristics and factors affecting fetal outcomes in twin pregnancies delivered by cesarean section.

Detailed Description

While the frequency of multiple pregnancies varies significantly among societies and individuals, especially in middle and high-income countries, the rate of multiple pregnancies has shown a significant rise worldwide in recent years, with the frequent use of assisted reproductive techniques, which has increased due to an increase in maternal age and a decrease in fertility. As a result, multiple pregnancies constitute approximately 2-4% of all births. Multiple pregnancies are known to be associated with increased maternal and fetal risks compared to singleton pregnancies. While maternal mortality associated with a twin pregnancy is 2.5 times higher than in singleton pregnancy, adverse neonatal outcomes such as perinatal mortality, fetal growth restriction, and low birth weight are two to three times higher in twins than in singleton newborns. Moreover, neonatal near-miss, which refers to cases that almost resulted in death, is associated with multiple pregnancies. For all these reasons, the planned cesarean section has been advocated over planned vaginal delivery to reduce the risk of adverse neonatal outcomes (especially for the second-born twin). However, cesarean delivery is known to be associated with a higher risk of maternal morbidity and poor neonatal outcomes. The vast majority of these risks are related to maternal hypotension, prolonged uterine-incision-to-delivery time, and general anesthesia. From this perspective, we aimed to evaluate maternal and fetal characteristics and factors affecting fetal outcomes in twin pregnancies delivered by cesarean section.

Registry
clinicaltrials.gov
Start Date
January 1, 2017
End Date
February 1, 2020
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Derince Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Hande Gurbuz

Medical Doctor, Associate Professor, Principal Investigator

Bursa Yüksek İhtisas Education and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • Twin pregnancies
  • Parturients delivered by cesarean section

Exclusion Criteria

  • The triplets or more multiple pregnancies
  • Twins delivered through the vaginal route were excluded from the study.

Outcomes

Primary Outcomes

The Rate of Death

Time Frame: 28 days

Neonatal mortality within the first 28 days after birth.

Appearance-Pulse-Grimace-Activity-Respiration-1st minute (worst:0; best:10)

Time Frame: 1 minute

Appearance-Pulse-Grimace-Activity-Respiration (APGAR) score at the 1st minute after delivery

Appearance-Pulse-Grimace-Activity-Respiration-5th minute (worst:0; best:10)

Time Frame: 5 minute

Appearance-Pulse-Grimace-Activity-Respiration (APGAR) score at the 5th minute after delivery

The Number of Participants Admitted to Neonatal Intensive Care Unit

Time Frame: 1 hour

Admission to Neonatal Intensive Care Unit after delivery

The Number of Participants needed for Mechanical ventilation

Time Frame: 28 days

The need for non-invasive and invasive mechanical ventilation

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