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The aim of the current study was to produce a high quality evidence on the best frequency of performing umbilical artery Doppler for high risk pregnant women in the third trimester.
Nowadays, high risk pregnancy forms a significant increasing proportion of any pregnant population, according to some authors up to 50% of all pregnancies would have the label of high risk pregnancies.
At present, it is recommended that high risk pregnancies, thought to be at risk of placental insufficiency should be monitored with Doppler studies of the umbilical artery. Doppler assessment of the placental circulation plays an important role in screening for impaired placentation and its complications of intrauterine growth restriction.
The purpose of umbilical artery Doppler surveillance is to predict fetal academia thereby allowing timely delivery prior to irreversible end-organ damage and intrauterine fetal death.
According to a Cochrane Pregnancy and Childbirth Group's systematic review and meta-analysis, in which Published and unpublished randomised and quasi-randomised trials evaluating the effects of one or more described antenatal fetal surveillance regimens were searched, the optimal frequency of umbilical artery Doppler surveillance is unclear.
Our randomized controlled study was conducted on patients with high risk pregnancies at their third trimester who attended Ain Shams University Maternity Hospital. A total of 292 high risk pregnant women fulfilling the inclusion criteria were selected by random sampling and divided between two groups with 146 patients in each group. Group I underwent Doppler every other week and Group II underwent Doppler once weekly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bi-Weekly Umbilical Artery Doppler | Active Comparator | will undergo Doppler every other week |
|
| Weekly Umbilical Artery Doppler | Experimental | will undergo Doppler every week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical artery Doppler | Diagnostic Test | Umbilical artery Doppler ultrasound will be performed by most expert sonographer in umbilical artery Doppler at the special care unit, using a 3.5MHz transabdominal probe of SAMSUNG MEDISON, SONOACE R5 ultrasound machine, using the standard protocol of the unit for minimizing the interobserver variations. |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal admission to r intensive care unit within the first 24 hours | Neonatal admission to special care and/or intensive care unit within the first 24 hours | first 24 hours of life |
| Measure | Description | Time Frame |
|---|---|---|
| Stillbirth | Stillbirth | at delivery |
| Neonatal death | Neonatal death | 28 days |
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Inclusion Criteria:
III-Patient considered as high-risk pregnancies will be included in this study.
The following will be considered as high-risk status:
Previous obstetric history of preeclampsia or eclampsia, abruptio placenta, intra-uterine growth restriction or still birth.
Pre-existing medical disorders like:
Current preeclampsia or pregnancy-induced hypertension (PIH). PIH is diagnosed in women whose blood pressure reaches 140/90 mm Hg or greater for the first time after midpregnancy, but proteinuria is not identified. Preeclampsia is best described as pregnancy-specific syndrome that can affect virtually every organ system.It is much more than simply gestational hypertension with proteinuria (Cunningham et al, 2010).
IV- Obtaining valid informed consent to participate in the study
Exclusion Criteria:
II- Patients with multiple gestations. As they have different growth pattern. III- Patients with unconfirmed Gestational age due to lack of sure reliable date and absent early trimesteric scan. As we cannot diagnose small for gestational age without sure date.
IV- Withdrawal of consent.
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| Name | Affiliation | Role |
|---|---|---|
| Ashraf F Nabhan, Professor | Faculty of Medicine, Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Maternity Hospital | Cairo | 11221 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11803092 | Result | Alfirevic Z, Roberts D, Martlew V. How strong is the association between maternal thrombophilia and adverse pregnancy outcome? A systematic review. Eur J Obstet Gynecol Reprod Biol. 2002 Feb 10;101(1):6-14. doi: 10.1016/s0301-2115(01)00496-1. | |
| 24222334 | Result | Alfirevic Z, Stampalija T, Gyte GM. Fetal and umbilical Doppler ultrasound in high-risk pregnancies. Cochrane Database Syst Rev. 2013 Nov 12;2013(11):CD007529. doi: 10.1002/14651858.CD007529.pub3. |
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The Investigator will make certain that an appropriate informed consent process is in place to ensure that potential research subjects are fully informed about the nature and objectives of the clinical study, the potential risks and benefits of study participation and their rights as research subjects.
The Investigator will obtain the written, signed informed consent of each subject prior to performing any study-specific procedures. The Investigator will retain the original signed informed consent form.
Personal information will not be collected or shared. Unique personal data will be her hospital number.
Participants files will be maintained in storage for a period of 3 years after completion of the study.
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Our randomized controlled study was conducted on patients with high risk pregnancies at their third trimester who attended Ain Shams University Maternity Hospital. A total of 292 high risk pregnant women fulfilling the inclusion criteria were selected by random sampling and divided between two groups with 146 patients in each group. Group I underwent Doppler every other week and Group II underwent Doppler once weekly
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Blinding of the patients or staff in this study is not generally feasible. However, the measured outcomes in this study are objective and are unlikely to be biased by lack of blinding.
|
| Fetal acidosis | cord blood pH | at delivery |
| Apgar score less than seven at five minutes | Apgar score less than seven at five minutes | 5 minutes |
| Induction of labour | Induction of labour | 24 hours |
| Preterm labour | onset of labour before 37 completed week of pregnancy | 37 weeks |
| Gestational age at birth | Gestational age at birth | 28 weeks |
| Infant respiratory distress syndrome | Infant respiratory distress syndrome | 24 hours |
| Hypoxic ischaemic encephalopathy | Hypoxic ischaemic encephalopathy | 96 hours |
| Intraventricular haemorrage | Intraventricular haemorrage | 96 hours |
| Necrotizing enterocolitis | Necrotizing enterocolitis | 96 hours |
| 36593702 | Derived | Salama MH, Rizk HH, Nawara M. Frequency of third trimester umbilical artery Doppler for improving neonatal outcomes in high-risk pregnancies: a randomized trial. Obstet Gynecol Sci. 2023 May;66(3):161-168. doi: 10.5468/ogs.22130. Epub 2023 Jan 3. |