Clinical trial NCT05104255: Neonatal Outcomes in Twin Pregnancies
Official title: Factors Influencing the Neonatal Outcomes in Twin Pregnancies Undergoing Cesarean Section: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Twin Pregnancy
Neonate
Keywords: General anesthesia
Neonate
Obstetric anesthesia
Pregnancy Outcomes
Spinal anesthesia
Twins
Twin pregnancy
Lead sponsor: Derince Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Bursa Yüksek İhtisas Education and Research Hospital
First posted: 2021-11-02
Enrollment: 527
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The twin newborns were delivered by cesarean section.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Appearance-Pulse-Grimace-Activity-Respiration-1st minute (worst:0; best:10)
timeFrame: 1 minute
measure: Appearance-Pulse-Grimace-Activity-Respiration-5th minute (worst:0; best:10)
timeFrame: 5 minute
measure: The Number of Participants Admitted to Neonatal Intensive Care Unit
timeFrame: 1 hour
measure: The Number of Participants needed for Mechanical ventilation
timeFrame: 28 days
measure: The Rate of Death
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bursa Yuksek Ihtisas Training and Research Hospital
name: Hande Gurbuz, Assoc. Prof.
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.
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/