Neonatal Outcomes in Twin Pregnancies

NCT05104255 | Completed

• 1 other identifier: 2019/05-26
• Study Type: observational
• Target: 527
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Twin Pregnancy; Neonate

Keywords

General anesthesia; Neonate; Obstetric anesthesia; Pregnancy Outcomes; Spinal anesthesia; Twins; Twin pregnancy

Outcome Measures

Primary Outcomes (5)

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

  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)

  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

  Admission to Neonatal Intensive Care Unit after delivery

  1 hour

• The Number of Participants needed for Mechanical ventilation

  The need for non-invasive and invasive mechanical ventilation

  28 days

• The Rate of Death

  Neonatal mortality within the first 28 days after birth.

  28 days

Study Arms (1)

Twin neonates

The demographic data and characteristics of the twins were evaluated.

Procedure: Spinal anesthesia; Procedure: General anesthesia

Interventions

Spinal anesthesia PROCEDURE

Twins delivered under under spinal anesthesia

Twin neonates

General anesthesia PROCEDURE

Twins delivered under general anesthesia

Twin neonates

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The twin newborns were delivered by cesarean section.

You may qualify if:

• Twin pregnancies
• Parturients delivered by cesarean section

You may not qualify if:

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

Sponsors & Collaborators

• Derince Training and Research Hospital: lead
• Bursa Yuksek Ihtisas Training and Research Hospital: collaborator

Related Publications (5)

• Young BC, Wylie BJ. Effects of twin gestation on maternal morbidity. Semin Perinatol. 2012 Jun;36(3):162-8. doi: 10.1053/j.semperi.2012.02.007.

  PMID: 22713496 RESULT

• Santana DS, Surita FG, Cecatti JG. Multiple Pregnancy: Epidemiology and Association with Maternal and Perinatal Morbidity. Rev Bras Ginecol Obstet. 2018 Sep;40(9):554-562. doi: 10.1055/s-0038-1668117. Epub 2018 Sep 19.

  PMID: 30231294 RESULT

• Cheong-See F, Schuit E, Arroyo-Manzano D, Khalil A, Barrett J, Joseph KS, Asztalos E, Hack K, Lewi L, Lim A, Liem S, Norman JE, Morrison J, Combs CA, Garite TJ, Maurel K, Serra V, Perales A, Rode L, Worda K, Nassar A, Aboulghar M, Rouse D, Thom E, Breathnach F, Nakayama S, Russo FM, Robinson JN, Dodd JM, Newman RB, Bhattacharya S, Tang S, Mol BW, Zamora J, Thilaganathan B, Thangaratinam S; Global Obstetrics Network (GONet) Collaboration. Prospective risk of stillbirth and neonatal complications in twin pregnancies: systematic review and meta-analysis. BMJ. 2016 Sep 6;354:i4353. doi: 10.1136/bmj.i4353.

  PMID: 27599496 RESULT

• National Collaborating Centre for Women's and Children's Health (UK). Multiple Pregnancy: The Management of Twin and Triplet Pregnancies in the Antenatal Period. London: RCOG Press; 2011 Sep. Available from http://www.ncbi.nlm.nih.gov/books/NBK83105/

  PMID: 22855972 RESULT

• Kilicarslan N, Gurbuz H, Tasgoz FN, Karaca U, Karasu D, Gamli M. Factors influencing neonatal outcomes in twin pregnancies undergoing cesarean section: a cross-sectional study. Rev Assoc Med Bras (1992). 2023 May 19;69(5):e20221464. doi: 10.1590/1806-9282.20221464. eCollection 2023.

  PMID: 37222324 DERIVED

MeSH Terms

Interventions

Anesthesia, Spinal; Anesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Hande Gurbuz, Assoc. Prof.

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 2, 2021
• Study Start: January 1, 2017
• Primary Completion: January 31, 2020
• Study Completion: February 1, 2020
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning nine months following a possible publication and ending after one year.