Twin PregnancyNCT05104255
Neonatal Outcomes in Twin Pregnancies
An observational study of Twin Pregnancy and Neonate, run by Derince Training and Research Hospital.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Twin Pregnancy, Neonate
- What is being tested?
- Spinal anesthesia and General anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 527 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The twin newborns were delivered by cesarean section.
Who may be able to join
- Twin pregnancies
- Parturients delivered by cesarean section
Who cannot join
- The triplets or more multiple pregnancies
- Twins delivered through the vaginal route were excluded from the study.
About this study
Official title: 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.
Read the 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.
- Conditions
- Twin Pregnancy, Neonate
- Being tested
- Spinal anesthesia, General anesthesia
- Keywords
- General anesthesia, Neonate, Obstetric anesthesia, Pregnancy Outcomes, Spinal anesthesia, Twins, Twin pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesiaProcedure or surgery
Twins delivered under under spinal anesthesia
General anesthesiaProcedure or surgery
Twins delivered under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Twin neonates | The demographic data and characteristics of the twins were evaluated. Receives: Procedure: Spinal anesthesia; Procedure: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appearance-Pulse-Grimace-Activity-Respiration-1st minute (worst:0; best:10)
Appearance-Pulse-Grimace-Activity-Respiration (APGAR) score at the 1st minute after delivery
Measured: 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
Measured: 5 minute
The Number of Participants Admitted to Neonatal Intensive Care Unit
Admission to Neonatal Intensive Care Unit after delivery
Measured: 1 hour
The Number of Participants needed for Mechanical ventilation
The need for non-invasive and invasive mechanical ventilation
Measured: 28 days
The Rate of Death
Neonatal mortality within the first 28 days after birth.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start1 Jan 2017
- Primary completion31 Jan 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Twin PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 527 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derince Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bursa Yuksek Ihtisas Training and Research Hospital
- Responsible party
- Principal investigator, Hande Gurbuz, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Hande Gurbuz, Assoc. Prof., Study director, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104255
- Sponsor's protocol ID
- 2019/05-26
- Status last verified
- Feb 2024
- First submitted
- 21 Oct 2021
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual, de-identified participant data will be shared with the researchers who provide a methodologically sound proposal.
Publications
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.
PubMed 22713496Santana 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.
PubMed 30231294Cheong-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.
PubMed 27599496National 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/
PubMed 22855972Kilicarslan 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.
PubMed 37222324
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing the Neonatal Outcomes in Twin Pregnancies Undergoing Cesarean Section: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05104255
- Acronym / sponsor ID
- 2019/05-26
- Conditions
- Twin Pregnancy, Neonate
- Keywords
- General anesthesia, Neonate, Obstetric anesthesia, Pregnancy Outcomes, Spinal anesthesia, Twins, Twin pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 527 participants (actual)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Collaborators
- Bursa Yuksek Ihtisas Training and Research Hospital
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Twin neonates | – | Procedure: Spinal anesthesia, Procedure: General anesthesiaThe demographic data and characteristics of the twins were evaluated. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The twin newborns were delivered by cesarean section.
Key inclusion criteria (2 listed)
- Twin pregnancies
- Parturients delivered by cesarean section
Key exclusion criteria (2 listed)
- The triplets or more multiple pregnancies
- Twins delivered through the vaginal route were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal anesthesiaTwins delivered under under spinal anesthesia | Procedure or surgery | Twin neonates |
| General anesthesiaTwins delivered under general anesthesia | Procedure or surgery | Twin neonates |
Primary outcome
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
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
The Number of Participants Admitted to Neonatal Intensive Care Unit
Time frame: 1 hour
Admission to Neonatal Intensive Care Unit after delivery
The Number of Participants needed for Mechanical ventilation
Time frame: 28 days
The need for non-invasive and invasive mechanical ventilation
The Rate of Death
Time frame: 28 days
Neonatal mortality within the first 28 days after birth.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Results publication: PubMed 22713496Young 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.
- Results publication: PubMed 30231294Santana 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.
- Results publication: PubMed 27599496Cheong-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.
- Results publication: PubMed 22855972National 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/
- Derived from this study: PubMed 37222324Kilicarslan 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.
- Individual participant dataSharing planned: Yes. Individual, de-identified participant data will be shared with the researchers who provide a methodologically sound proposal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hande Gurbuz, Assoc. Prof. study director
Bursa Yuksek Ihtisas Training and Research Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Twin Pregnancy and Neonate, run by Derince Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appearance-Pulse-Grimace-Activity-Respiration-1st minute (worst:0; best:10) (time frame: 1 minute). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05104255, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.