Neonatal Outcomes in Twin Pregnancies

Neonate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05104255
• Other study ID #: 2019/05-26
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: February 1, 2020

Study information

• Verified date: February 2024
• Source: Derince Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 527
• Est. completion date: February 1, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Neonate
• Twin Pregnancy

Intervention

Procedure:
• Spinal anesthesia
Twins delivered under under spinal anesthesia
• General anesthesia
Twins delivered under general anesthesia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Derince Training and Research Hospital	Bursa Yüksek Ihtisas Education and Research Hospital

References & Publications (4)

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, Breathn — View Citation

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/ — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	The Number of Participants Admitted to Neonatal Intensive Care Unit	Admission to Neonatal Intensive Care Unit after delivery	1 hour
Primary	The Number of Participants needed for Mechanical ventilation	The need for non-invasive and invasive mechanical ventilation	28 days
Primary	The Rate of Death	Neonatal mortality within the first 28 days after birth.	28 days