Neonatal Outcomes in Twin Pregnancies

February 16, 2024 updated by: Hande Gurbuz, Derince Training and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

527

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The twin newborns were delivered by cesarean section.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Twin neonates
The demographic data and characteristics of the twins were evaluated.
Procedure: Spinal anesthesia
Twins delivered under under spinal anesthesia
Procedure: General anesthesia
Twins delivered under general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 minute
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
5 minute
The Number of Participants Admitted to Neonatal Intensive Care Unit
Time Frame: 1 hour
Admission to Neonatal Intensive Care Unit after delivery
1 hour
The Number of Participants needed for Mechanical ventilation
Time Frame: 28 days
The need for non-invasive and invasive mechanical ventilation
28 days
The Rate of Death
Time Frame: 28 days
Neonatal mortality within the first 28 days after birth.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Derince Training and Research Hospital

Collaborators

Bursa Yüksek İhtisas Education and Research Hospital

Investigators

  • Study Director: Hande Gurbuz, Assoc. Prof., Bursa Yuksek Ihtisas Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

January 31, 2020

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

October 21, 2021

First Submitted That Met QC Criteria

October 21, 2021

First Posted (Actual)

November 2, 2021

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/05-26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual, de-identified participant data will be shared with the researchers who provide a methodologically sound proposal.

IPD Sharing Time Frame

Beginning nine months following a possible publication and ending after one year.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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