Intrapartum Fetal DistressNCT07881744
Prediction of Intrapartum Fetal Compromise After Elective Induction of Labour
An observational study of Intrapartum Fetal Distress, run by Ain Shams Maternity Hospital.
Trial summary
Each fetus has a different metabolic capacity at the onset of labor, and in cases of an imbalance between fetal demands and placental oxygen supply, fetal hypoxia occurs. In this scenario, and to avoid permanent fetal damage, a cesarean section (CS) for intrapartum fetal compromise (IFC) might be needed to minimize… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Intrapartum Fetal Distress
- How many people
- 182 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult
Study population: Pregnant women scheduled for elective induction of labour at term.
Who may be able to join
- Singleton pregnancy
- Gestational age ≥37 weeks
- Intact membranes
- Planned elective induction of labour
Who cannot join
- Refusal to participate in the study.
- Multiple pregnancy
- fetal anomalies
- Fetal growth restriction
- Contraindications for vaginal delivery(women with Contraindications for vaginal birth are not candidates for labour induction) 6. Medical diseases which could affect fetal growth (DM, HTN, etc)( maternal medical disorders may alter placental perfusion,fetal growth and Doppler indices)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Accuracy of Doppler Cerebroplacental Ratio in Prediction of Intrapartum Fetal Compromise After Elective Induction of Labour
Each fetus has a different metabolic capacity at the onset of labor, and in cases of an imbalance between fetal demands and placental oxygen supply, fetal hypoxia occurs. In this scenario, and to avoid permanent fetal damage, a cesarean section (CS) for intrapartum fetal compromise (IFC) might be needed to minimize the potential consequences of sustained hypoxia.
Read the detailed description
Acute fetal compromise is one of the leading causes of perinatal morbidity and mortality worldwide. As well as being a major cause of fetal death, a reduction in the oxygen supply for the conceptus can lead to relevant neonatal complications. Intrapartum fetal compromise (IFC) occurs in a significant proportion (10-15%) of cases of intrapartum hypoxia-ischemia. In most cases, Intra-partum fetal compromise occurs in low-risk pregnancies, making adverse perinatal outcomes difficult to predict.
The placenta is the organ in charge of supplying the fetus with enough nutrition to allow its appropriate growth during pregnancy, and it also copes with different hypoxic insults. Labor is a physiological but stressful situation for the fetus and the mother, characterized by repeated transient episodes of uterine contractions, causing fetal intermittent hypoxia. Each uterine contraction is associated with an increase in intrauterine pressure by 25 to 70 mmHg, resulting in a 25% drop in the partial pressure of oxygen at the fetal side.
Cerebroplacental ratio is widely used to diagnose adverse perinatal outcomes as it assesses the correlation between fetal cerebral redistribution and hypoxemia, which is independent of birth weight.This, has consequences for assessing the well-being of small for gestational age(SGA) and appropriate for gestational age(AGA) fetuses close to the end of pregnancy.
A key clinical goal before labour onset is to predict fetal intolerance to labour, intrapartum fetal compromise from hypoxia, emergency caesarean delivery, and subsequent serious perinatal morbidity and mortality.
When the fetus suffers hypoxia, one of its multiple adaptive mechanisms is the centralization of blood flow to the most noble organs, such as the fetal brain. This situation can be evaluated with Doppler ultrasound measuring the cerebro-placental ratio (CPR), Calculated by dividing the Doppler flow rate of the middle cerebral artery (MCA) by the flow rate of the umbilical artery (UA). the CPR is an obstetric US measurement that demonstrates how elevated placental resistance and fetal hypoxia lead to the redistribution of cardiac output to the cerebral circulation.
The cerebroplacental ratio evaluation is used to detect and assess the fetal response to oxygen defciency in utero. With the progress of pregnancy, the resistance in fetal circulation decreases gradually. Nevertheless, the values of middle cerebral artery pulsatility index (MCA PI) should remain higher than umbilical artery pulsatility index (UA PI) values, which implicates that CPR, being the ratio of (MCA PI) to (UA PI), should be higher than 1 in uncomplicated pregnancies.
- Conditions
- Intrapartum Fetal Distress
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrapartum fetal distress
Intrapartum fetal compromise requiring operative delivery (instrumental vaginal delivery or cesarean section)
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Intrapartum Fetal DistressStudies 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
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohammed Elmaraghy, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881744
- Sponsor's protocol ID
- 22
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fracalozzi JL, Okido MM, Crott GC, Duarte G, Cavalli RC, Araujo Junior E, Peixoto AB, Marcolin AC. Maternal, obstetric, and fetal Doppler characteristics in a high-risk population: prediction of adverse perinatal outcomes and of cesarean section due to intrapartum fetal compromise. Radiol Bras. 2023 Jul-Aug;56(4):179-186. doi: 10.1590/0100-3984.2022.0104.
PubMed 37829588Maity, A., Sonawane, B., Deshpande, A., & Bhutada, S. (2024). Diagnostic accuracy of cerebroplacental ratio in anticipating adverse perinatal outcome in uncomplicated appropriate for gestational age pregnancies at term. Journal of Indira Gandhi Institute Of Medical Science, 10(2), 125-132.
Mohamed, M.L., Mohamed, S.A. & Elshahat, A.M. Cerebroplacental ratio for prediction of adverse intrapartum and neonatal outcomes in a term uncomplicated pregnancy. Middle East Fertil Soc J 26, 45 (2021). https://doi.org/10.1186/s43043-021-00090-3
Mushtaq, S., Amin, M., & KHAN, M. (2025). PROGNOSTIC ACCURACY OF CEREBROPLACENTAL RATIO FOR ADVERSE FETAL OUTCOMES AND FETAL DISTRESS WITHIN 24 HOURS OF BIRTH. Pakistan Journal of Intensive Care Medicine, 5(01), 86.
Novillo-Del Alamo B, Martinez-Varea A, Nieto-Tous M, Padilla-Prieto C, Modrego-Pardo F, Bello-Martinez de Velasco S, Garcia-Florenciano MV, Morales-Rosello J. Prediction of Cesarean Section for Intrapartum Fetal Compromise: A Multivariable Model from a Prospective Observational Approach. J Pers Med. 2024 Jun 20;14(6):658. doi: 10.3390/jpm14060658.
PubMed 38929879Novillo-Del Alamo B, Martinez-Varea A, Satorres-Perez E, Nieto-Tous M, Bello-Martinez de Velasco S, Garcia-Florenciano MV, Padilla-Prieto C, Modrego-Pardo F, Morales-Rosello J. Cerebroplacental Ratio as a Predictive Factor of Emergency Cesarean Sections for Intrapartum Fetal Compromise: A Systematic Review. J Clin Med. 2024 Mar 17;13(6):1724. doi: 10.3390/jcm13061724.
PubMed 38541949Ortiz JU, Graupner O, Flechsenhar S, Karge A, Ostermayer E, Abel K, Kuschel B, Lobmaier SM. Prognostic Value of Cerebroplacental Ratio in Appropriate-for-Gestational-Age Fetuses Before Induction of Labor in Late-Term Pregnancies. Ultraschall Med. 2023 Feb;44(1):50-55. doi: 10.1055/a-1399-8915. Epub 2021 May 31.
PubMed 34058782Reale SC, Farber MK. The cerebroplacental ratio: a new standard diagnostic tool at term gestation to assess fetal risk in labour? Lancet. 2024 Feb 10;403(10426):506-508. doi: 10.1016/S0140-6736(23)02453-4. Epub 2024 Jan 11. No abstract available.
PubMed 38219771
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Doppler Cerebroplacental Ratio in Prediction of Intrapartum Fetal Compromise After Elective Induction of Labour
- ClinicalTrials.gov ID
- NCT07881744
- Acronym / sponsor ID
- 22
- Conditions
- Intrapartum Fetal Distress
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 19 Oct 2026 (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.
Each fetus has a different metabolic capacity at the onset of labor, and in cases of an imbalance between fetal demands and placental oxygen supply, fetal hypoxia occurs. In this scenario, and to avoid permanent fetal damage, a cesarean section (CS) for intrapartum fetal compromise (IFC) might be needed to minimize the potential consequences of sustained hypoxia.
Detailed description
Acute fetal compromise is one of the leading causes of perinatal morbidity and mortality worldwide. As well as being a major cause of fetal death, a reduction in the oxygen supply for the conceptus can lead to relevant neonatal complications. Intrapartum fetal compromise (IFC) occurs in a significant proportion (10-15%) of cases of intrapartum hypoxia-ischemia. In most cases, Intra-partum fetal compromise occurs in low-risk pregnancies, making adverse perinatal outcomes difficult to predict.
The placenta is the organ in charge of supplying the fetus with enough nutrition to allow its appropriate growth during pregnancy, and it also copes with different hypoxic insults. Labor is a physiological but stressful situation for the fetus and the mother, characterized by repeated transient episodes of uterine contractions, causing fetal intermittent hypoxia. Each uterine contraction is associated with an increase in intrauterine pressure by 25 to 70 mmHg, resulting in a 25% drop in the partial pressure of oxygen at the fetal side.
Cerebroplacental ratio is widely used to diagnose adverse perinatal outcomes as it assesses the correlation between fetal cerebral redistribution and hypoxemia, which is independent of birth weight.This, has consequences for assessing the well-being of small for gestational age(SGA) and appropriate for gestational age(AGA) fetuses close to the end of pregnancy.
A key clinical goal before labour onset is to predict fetal intolerance to labour, intrapartum fetal compromise from hypoxia, emergency caesarean delivery, and subsequent serious perinatal morbidity and mortality.
When the fetus suffers hypoxia, one of its multiple adaptive mechanisms is the centralization of blood flow to the most noble organs, such as the fetal brain. This situation can be evaluated with Doppler ultrasound measuring the cerebro-placental ratio (CPR), Calculated by dividing the Doppler flow rate of the middle cerebral artery (MCA) by the flow rate of the umbilical artery (UA). the CPR is an obstetric US measurement that demonstrates how elevated placental resistance and fetal hypoxia lead to the redistribution of cardiac output to the cerebral circulation.
The cerebroplacental ratio evaluation is used to detect and assess the fetal response to oxygen defciency in utero. With the progress of pregnancy, the resistance in fetal circulation decreases gradually. Nevertheless, the values of middle cerebral artery pulsatility index (MCA PI) should remain higher than umbilical artery pulsatility index (UA PI) values, which implicates that CPR, being the ratio of (MCA PI) to (UA PI), should be higher than 1 in uncomplicated pregnancies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant women scheduled for elective induction of labour at term.
Key inclusion criteria (4 listed)
- Singleton pregnancy
- Gestational age ≥37 weeks
- Intact membranes
- Planned elective induction of labour
Key exclusion criteria (5 listed)
- Refusal to participate in the study.
- Multiple pregnancy
- fetal anomalies
- Fetal growth restriction
- Contraindications for vaginal delivery(women with Contraindications for vaginal birth are not candidates for labour induction) 6. Medical diseases which could affect fetal growth (DM, HTN, etc)( maternal medical disorders may alter placental perfusion,fetal growth and Doppler indices)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intrapartum fetal distress
Time frame: At delivery
Intrapartum fetal compromise requiring operative delivery (instrumental vaginal delivery or cesarean section)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Background: PubMed 37829588Fracalozzi JL, Okido MM, Crott GC, Duarte G, Cavalli RC, Araujo Junior E, Peixoto AB, Marcolin AC. Maternal, obstetric, and fetal Doppler characteristics in a high-risk population: prediction of adverse perinatal outcomes and of cesarean section due to intrapartum fetal compromise. Radiol Bras. 2023 Jul-Aug;56(4):179-186. doi: 10.1590/0100-3984.2022.0104.
- BackgroundMaity, A., Sonawane, B., Deshpande, A., & Bhutada, S. (2024). Diagnostic accuracy of cerebroplacental ratio in anticipating adverse perinatal outcome in uncomplicated appropriate for gestational age pregnancies at term. Journal of Indira Gandhi Institute Of Medical Science, 10(2), 125-132.
- BackgroundMohamed, M.L., Mohamed, S.A. & Elshahat, A.M. Cerebroplacental ratio for prediction of adverse intrapartum and neonatal outcomes in a term uncomplicated pregnancy. Middle East Fertil Soc J 26, 45 (2021). https://doi.org/10.1186/s43043-021-00090-3
- BackgroundMushtaq, S., Amin, M., & KHAN, M. (2025). PROGNOSTIC ACCURACY OF CEREBROPLACENTAL RATIO FOR ADVERSE FETAL OUTCOMES AND FETAL DISTRESS WITHIN 24 HOURS OF BIRTH. Pakistan Journal of Intensive Care Medicine, 5(01), 86.
- Background: PubMed 38929879Novillo-Del Alamo B, Martinez-Varea A, Nieto-Tous M, Padilla-Prieto C, Modrego-Pardo F, Bello-Martinez de Velasco S, Garcia-Florenciano MV, Morales-Rosello J. Prediction of Cesarean Section for Intrapartum Fetal Compromise: A Multivariable Model from a Prospective Observational Approach. J Pers Med. 2024 Jun 20;14(6):658. doi: 10.3390/jpm14060658.
- Background: PubMed 38541949Novillo-Del Alamo B, Martinez-Varea A, Satorres-Perez E, Nieto-Tous M, Bello-Martinez de Velasco S, Garcia-Florenciano MV, Padilla-Prieto C, Modrego-Pardo F, Morales-Rosello J. Cerebroplacental Ratio as a Predictive Factor of Emergency Cesarean Sections for Intrapartum Fetal Compromise: A Systematic Review. J Clin Med. 2024 Mar 17;13(6):1724. doi: 10.3390/jcm13061724.
- Background: PubMed 34058782Ortiz JU, Graupner O, Flechsenhar S, Karge A, Ostermayer E, Abel K, Kuschel B, Lobmaier SM. Prognostic Value of Cerebroplacental Ratio in Appropriate-for-Gestational-Age Fetuses Before Induction of Labor in Late-Term Pregnancies. Ultraschall Med. 2023 Feb;44(1):50-55. doi: 10.1055/a-1399-8915. Epub 2021 May 31.
- Background: PubMed 38219771Reale SC, Farber MK. The cerebroplacental ratio: a new standard diagnostic tool at term gestation to assess fetal risk in labour? Lancet. 2024 Feb 10;403(10426):506-508. doi: 10.1016/S0140-6736(23)02453-4. Epub 2024 Jan 11. No abstract available.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrapartum Fetal Distress, run by Ain Shams Maternity 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 19 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M ElMaraghy, M.D, (+201010370980, ahmedelmaraghy@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrapartum fetal distress (time frame: At delivery). 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 NCT07881744, which also lists 8 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 19 Oct 2026.