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OpenTrials
Completed

NCT Number: NCT05104255

Neonatal Outcomes in Twin Pregnancies

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spinal anesthesia

Procedure

Twins delivered under under spinal anesthesia

General Anesthesia

Procedure

Twins delivered under general anesthesia

Primary outcomes

  1. 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

  2. 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

  3. The Number of Participants Admitted to Neonatal Intensive Care Unit

    Time frame: 1 hour

    Admission to Neonatal Intensive Care Unit after delivery

  4. The Number of Participants needed for Mechanical ventilation

    Time frame: 28 days

    The need for non-invasive and invasive mechanical ventilation

  5. The Rate of Death

    Time frame: 28 days

    Neonatal mortality within the first 28 days after birth.

Sponsors and collaborators

Lead sponsor

Derince Training and Research Hospital

Other

Collaborators

  • Bursa Yuksek Ihtisas Training and Research Hospital

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 2, 2021
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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