Placental Growth Factor as a Predictor of Adverse Pregnancy Outcomes in Preeclamptic Women

NCT04374604 | Completed

• 1 other identifier: FETHA/REC/VOL2/2018/041
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Preeclampsia is one of the leading causes of maternal and perinatal morbidity and mortality worldwide, and it affects 3% to 8% of all pregnancies. Maternal and perinatal morbidity and mortality resulting from preeclampsia are due to its complications. Clinical prediction of complications associated with preeclampsia may facilitate initiation of timely management to reduce or avert adverse outcomes associated with the condition. Studies on current biomarkers (proteinuria or uric acid) have shown poor performance in the prediction of adverse pregnancy outcomes in preeclamptic women. Placental growth factor (PlGF) is an angiogenic growth factor that is exclusively produced by the trophoblast. Circulating levels of placental growth factor have been reported to be reduced in women with preeclampsia. Therefore there is a need to evaluate the predictive performance on adverse pregnancy outcomes of this pregnancy specific biomaker among preeclamptic women. Aim: To determine the predictive accuracy of maternal serum PlGF level for adverse pregnancy outcomes in preeclamptic women. Materials and Method: It is a prospective cohort study that will be conducted on 110 women that will be admitted for preeclampsia in the Federal Teaching Hospital and Saint Patrick Mile 4 Hospital Abakaliki. On admission women who will give informed consent will have their blood sample collected. The sample will be analysed using Enzyme linked Immunosorbent Assay technique to determine the level of PlGF (pg/ml). All the study participants will be followed up until delivery. The socio-demographic characteristics and maternal and perinatal adverse outcomes will be entered into a proforma. Data will be entered and analyzed using SPSS version 22.0. Strength and limitation: The strength of the study is that a single biomaker, PlGF, will be assayed and the test will be performed once, which is cost-saving. The limitation of this study is that there would not be long term follow up of participants after hospital discharge and so complications that will occur after discharge will not be assessed. Conclusion: Considering the contribution of preeclampsia to maternal morbidity and mortality in Abakaliki and poor predictive performance of available biochemical markers on adverse pregnancy outcomes among preeclamptic women, there is need to conduct this study so as to ascertain the utility of PlGF in predicting adverse outcome among preeclamptic women in Abakaliki.

Conditions

Pre-Eclampsia

Keywords

Placental growth factor; Prediction; Adverse pregnancy outcomes; Pre-eclampsia

Outcome Measures

Primary Outcomes (2)

• Composite of adverse maternal outcome

  Adverse maternal outcomes will include one or more of: disseminated intravascular coagulation (DIC), HELLP syndrome, abruptio placentae, pulmonary oedema, intracerebral haemorrhage, acute left ventricular failure, renal insufficiency (creatinine \>90 umol/l), liver disease (aspartate aminotransferase \>40 U/l), eclampsia and maternal death.

  The outcome measure will be assessed from the time of enrollment to one week after delivery

• Composite of adverse fetal outcome

  Adverse fetal outcomes will include one or more of: Apgar score \<7 at the 5th minute, small-for-gestational-age infant (SGA; \<10th centile), admission to special-care nursery, fetal death and early neonatal death.

  The outcome measure will be assessed from the time of enrollment to one week after delivery

Study Arms (1)

Paturients with preeclampisia

The participants will be pregnant women with late-onset pre-eclampsia

Diagnostic Test: Placental growth factor

Interventions

Placental growth factor DIAGNOSTIC_TEST

On admission, the blood samples of consenting participants will be collected and analysed using enzyme linked immunosorbent assay technique to determine the level of PlGF (pg/ml).

Paturients with preeclampisia

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study participants will be drawn from pregnant women with late-onset preeclampsia attending antenatal care at the study facilities during the study period.

You may qualify if:

• Singleton pregnancy
• Gestational age up to 34 weeks and above

You may not qualify if:

• Multiple pregnancy
• Gestational age less than 34 weeks

Sponsors & Collaborators

• Johnbosco Ifunanya Nwafor: lead

Study Sites (1)

Alex Ekwuueme Federal University Teaching Hospital

Abakaliki, Ebonyi State, 840001, Nigeria

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 5, 2020
• Study Start: October 1, 2018
• Primary Completion: July 22, 2019
• Study Completion: July 31, 2019
• Last Updated: May 5, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: 2 years
• Access Criteria: It will be made available on request from the corresponding author

Locations

NG (1)