Neonate Clinical Trial
Official title:
Factors Influencing the Neonatal Outcomes in Twin Pregnancies Undergoing Cesarean Section: a Cross-sectional Study
NCT number | NCT05104255 |
Other study ID # | 2019/05-26 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2017 |
Est. completion date | February 1, 2020 |
Verified date | February 2024 |
Source | Derince Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Derince Training and Research Hospital | Bursa Yüksek Ihtisas Education and Research Hospital |
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
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 |
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