Neonatal Outcomes in Twin Pregnancies

Completed

• Conditions: Neonate; Twin Pregnancy
• Interventions: Procedure: Spinal anesthesia; Procedure: General anesthesia

• Registration Number: NCT05104255
• Lead Sponsor: Derince Training and Research Hospital

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.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2020-01-31
• Study Completion: 2020-02-01
• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-10-21
• Study First Posted: 2021-11-02
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 527

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Twin neonates	Spinal anesthesia	The demographic data and characteristics of the twins were evaluated.
Twin neonates	General anesthesia	The demographic data and characteristics of the twins were evaluated.

Primary Outcome Measures

Name	Time	Method
The Rate of Death	28 days	Neonatal mortality within the first 28 days after birth.
Appearance-Pulse-Grimace-Activity-Respiration-1st minute (worst:0; best:10)	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)	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	1 hour	Admission to Neonatal Intensive Care Unit after delivery
The Number of Participants needed for Mechanical ventilation	28 days	The need for non-invasive and invasive mechanical ventilation