NCT04374604

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

Completed Last updated 5 May 2020

What this trial tests

trial testing Placental growth factor in Pre-Eclampsia in 140 participants. Completed in 31 July 2019.

Timeline

1 October 2018

Primary endpoint
22 July 2019

31 July 2019

Quick facts

Lead sponsor	Johnbosco Ifunanya Nwafor
Status	Completed
Study type	OBSERVATIONAL
Enrollment	140
Start date	1 October 2018
Primary completion	22 July 2019
Estimated completion	31 July 2019
Sites	1 location across Nigeria

Drugs / interventions tested

• Placental growth factor

Conditions studied

• Pre-Eclampsia — all drugs for Pre-Eclampsia →

Sponsor

Johnbosco Ifunanya Nwafor

Who can join

Adults 18 to 45, female only, with Pre-Eclampsia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.