Term PregnancyDopplerNCT04158609
Relationship Between Delivery Route and Fetal Complications With Doppler Indices and CPR Parameters
An observational study of Term Pregnancy and Doppler Parameters, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
Term pregnancies within their 37-41 gestational week, who were planned to undergo induction of labor, were included in the study. Prior to initiation of the induction of labor, all included pregnant women underwent an assessment of Doppler flow indices, which included fetal umblical artery PI (pulsatility index) and… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Term Pregnancy, Doppler Parameters, Induction of Labor
- What is being tested?
- Doppler flow indices assessment
- How many people
- 145 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2018to 31 Oct 2019
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Term pregnancies within their 37-41 gestational week, who were planned to undergo induction of labor, were included in the study. Prior to initiation of the induction of labor, all included pregnant women underwent an assessment of Doppler flow indices, which included fetal umblical artery PI (pulsatility index) and fetal middle cerebral artery (MCA:Middle cerebral arter) PI.
Who may be able to join
- Term pregnancies between 37 and 41 gestational weeks Pregnancies destined to induction of labor
Who cannot join
- history of uterine scar, nonverteks presentation, multiple pregnancies, use of vacuum of forceps at delivery, shoulder dystocia, confirmed fetal structural or chromosomal anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Relationship Between Delivery Route, Umbilical Cord pH and Fetal Complications With Doppler Parameters Measured Prior to Induction of Labor at Term Pregnancies.
Term pregnancies within their 37-41 gestational week, who were planned to undergo induction of labor, were included in the study. Prior to initiation of the induction of labor, all included pregnant women underwent an assessment of Doppler flow indices, which included fetal umblical artery PI (pulsatility index) and fetal middle cerebral artery (MCA:Middle cerebral arter) PI. Cerebroplacental Ratio (CPR) was calculated by dividing MCA PI value to umbilical artery PI (MCA PI/UA PI=CPR).Included pregnant women were categorized as Group 1 and Group 2, which comprised of those with CPR value below 1.0 and above 1.0, respectively. Route of delivery and fetal complications, described as umbilical cord pH<7.20, APGAR score at 5 minutes <7, meconium aspiration syndrome, newborn intensive care unit admission, neonatal sepsis and neonatal death.
Read the detailed description
Term pregnancies within their 37-41 gestational week, who were planned to undergo induction of labor, were included in the study. Prior to initiation of the induction of labor, all included pregnant women underwent an assessment of Doppler flow indices, which included fetal umblical artery PI (pulsatility index) and fetal middle cerebral artery (MCA:Middle cerebral arter) PI. Cerebroplacental Ratio (CPR) was calculated by dividing MCA PI value to umbilical artery PI (MCA PI/UA PI=CPR).Included pregnant women were categorized as Group 1 and Group 2, which comprised of those with CPR value below 1.0 and above 1.0, respectively. All women who were considered appropriate for induction of labor were performed an pelvic examination and their Bishop scores were calculated. Those with a Bishop score equal to or below 5 were included in the study. Vaginal misoprostol (prostoglandin E1, 25 mcg) and dinoproston (prostoglandin E2, 10 mg) were used for induction of labor. Repeat doses were implemented in case of insufficient cervical ripening. Oxytocin was not used at the initial stages of labour, while it was used at the latter stages when necessary.
Route of delivery and fetal complications, described as umbilical cord pH<7.20, APGAR score at 5 minutes <7, meconium aspiration syndrome, newborn intensive care unit admission, neonatal sepsis and neonatal death.
- Being tested
- Doppler flow indices assessment
- Keywords
- term pregnancy, Doppler parameters, Cerebroplacental ratio, Induction of labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler flow indices assessmentDiagnostic test
Doppler flow indices, UA-PI, MCA-PI and CPR values, assessment performed prior to induction of labor
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Pregnant women with CPR value below 1, based on Doppler indices assessment Receives: Diagnostic Test: Doppler flow indices assessment | |
| Group 2 | Pregnant women with CPR value equal to or above 1, based on Doppler indices assessment Receives: Diagnostic Test: Doppler flow indices assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Umblical arter pH
Umbilical cord blood sampling just after the delivery of the newborn and pH measurement
Measured: Within 1-3 minutes following delivery
APGAR score at 5 minutes
APGAR score determined by the pediatrician at postpartum 5 minutes
Measured: Postpartum 5 minutes
Meconium aspiration syndrome
Meconium aspiration syndrome diagnosed by the pediatrician, either clinically or by thorax X-ray film.
Measured: Within postpartum two weeks
Newborn intensive care unit administration
Newborn intensive care unit administration, due to a variety of conditions, which were established by pediatrician
Measured: Within postpartum 1 month period
Neonatal sepsis
Neonatal sepsis diagnosed by the pediatrician
Measured: Within postpartum 1 month period
Neonatal death
Neonatal death
Measured: Within postpartum 1 month period
Secondary outcomes (1)
Route of delivery
Route of delivery, either vaginally or by cesarean section
Measured: At the time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start1 Dec 2018
- Primary completion30 Sep 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Term 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
- Prospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özkan Özdamar, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158609
- Sponsor's protocol ID
- 2018/0473
- Acronym
- Doppler
- Status last verified
- Nov 2019
- First submitted
- 7 Nov 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Relationship Between Delivery Route, Umbilical Cord pH and Fetal Complications With Doppler Parameters Measured Prior to Induction of Labor at Term Pregnancies.
- ClinicalTrials.gov ID
- NCT04158609
- Acronym / sponsor ID
- Doppler / 2018/0473
- Keywords
- term pregnancy, Doppler parameters, Cerebroplacental ratio, Induction of labor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 12 Nov 2019 (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.
Term pregnancies within their 37-41 gestational week, who were planned to undergo induction of labor, were included in the study. Prior to initiation of the induction of labor, all included pregnant women underwent an assessment of Doppler flow indices, which included fetal umblical artery PI (pulsatility index) and fetal middle cerebral artery (MCA:Middle cerebral arter) PI. Cerebroplacental Ratio (CPR) was calculated by dividing MCA PI value to umbilical artery PI (MCA PI/UA PI=CPR).Included pregnant women were categorized as Group 1 and Group 2, which comprised of those with CPR value below 1.0 and above 1.0, respectively. Route of delivery and fetal complications, described as umbilical cord pH<7.20, APGAR score at 5 minutes <7, meconium aspiration syndrome, newborn intensive care unit admission, neonatal sepsis and neonatal death.
Detailed description
Term pregnancies within their 37-41 gestational week, who were planned to undergo induction of labor, were included in the study. Prior to initiation of the induction of labor, all included pregnant women underwent an assessment of Doppler flow indices, which included fetal umblical artery PI (pulsatility index) and fetal middle cerebral artery (MCA:Middle cerebral arter) PI. Cerebroplacental Ratio (CPR) was calculated by dividing MCA PI value to umbilical artery PI (MCA PI/UA PI=CPR).Included pregnant women were categorized as Group 1 and Group 2, which comprised of those with CPR value below 1.0 and above 1.0, respectively. All women who were considered appropriate for induction of labor were performed an pelvic examination and their Bishop scores were calculated. Those with a Bishop score equal to or below 5 were included in the study. Vaginal misoprostol (prostoglandin E1, 25 mcg) and dinoproston (prostoglandin E2, 10 mg) were used for induction of labor. Repeat doses were implemented in case of insufficient cervical ripening. Oxytocin was not used at the initial stages of labour, while it was used at the latter stages when necessary.
Route of delivery and fetal complications, described as umbilical cord pH<7.20, APGAR score at 5 minutes <7, meconium aspiration syndrome, newborn intensive care unit admission, neonatal sepsis and neonatal death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Doppler flow indices assessmentPregnant women with CPR value below 1, based on Doppler indices assessment |
| Group 2 | – | Diagnostic Test: Doppler flow indices assessmentPregnant women with CPR value equal to or above 1, based on Doppler indices assessment |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Term pregnancies within their 37-41 gestational week, who were planned to undergo induction of labor, were included in the study. Prior to initiation of the induction of labor, all included pregnant women underwent an assessment of Doppler flow indices, which included fetal umblical artery PI (pulsatility index) and fetal middle cerebral artery (MCA:Middle cerebral arter) PI.
Key inclusion criteria (1 listed)
- Term pregnancies between 37 and 41 gestational weeks Pregnancies destined to induction of labor
Key exclusion criteria (1 listed)
- history of uterine scar, nonverteks presentation, multiple pregnancies, use of vacuum of forceps at delivery, shoulder dystocia, confirmed fetal structural or chromosomal anomalies
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 |
|---|---|---|
| Doppler flow indices assessmentDoppler flow indices, UA-PI, MCA-PI and CPR values, assessment performed prior to induction of labor | Diagnostic test | Group 1, Group 2 |
Primary outcome
Umblical arter pH
Time frame: Within 1-3 minutes following delivery
Umbilical cord blood sampling just after the delivery of the newborn and pH measurement
APGAR score at 5 minutes
Time frame: Postpartum 5 minutes
APGAR score determined by the pediatrician at postpartum 5 minutes
Meconium aspiration syndrome
Time frame: Within postpartum two weeks
Meconium aspiration syndrome diagnosed by the pediatrician, either clinically or by thorax X-ray film.
Newborn intensive care unit administration
Time frame: Within postpartum 1 month period
Newborn intensive care unit administration, due to a variety of conditions, which were established by pediatrician
Neonatal sepsis
Time frame: Within postpartum 1 month period
Neonatal sepsis diagnosed by the pediatrician
Neonatal death
Time frame: Within postpartum 1 month period
Neonatal death
1 secondary outcome
Route of delivery
Time frame: At the time of delivery
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 13 Nov 2019.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Term Pregnancy and Doppler Parameters, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Umblical arter pH (time frame: Within 1-3 minutes following delivery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2019; AzTrials last refreshed its copy on 6 Nov 2026.