NCT03213639

Brief Summary

Pre-eclampsia is one of the most serious complications of pregnancy affecting 3-8 % of pregnancies worldwide. It is a multi-system disorder involving maternal vessels (causing hypertension and endothelial dysfunction), the kidneys, the liver, the lungs, the hematological system, the cardiovascular system and the feto-placental unit. In its most severe form, it affects the brain, causing seizures (eclampsia), cerebro-vascular events and even death.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

March 15, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2020

Completed
Last Updated

January 7, 2021

Status Verified

January 1, 2021

Enrollment Period

2.3 years

First QC Date

July 8, 2017

Last Update Submit

January 6, 2021

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (2)

  • Number of women who develop HELLP syndrome

    1 month

  • The change in serum level of sFlt-1 and endoglin before the start of treatment and at termination of pregnancy

    2 weeks

Secondary Outcomes (2)

  • Prolongation of gestation measured from the time of enrollment to the time of delivery

    2 weeks

  • The side effects of the drugs

    2 weeks

Study Arms (2)

study group

EXPERIMENTAL

Patients will take esomeprazole single dose of 40 mg orally once a day

Drug: Esomeprazole 40 mg Oral Tablet

control group

PLACEBO COMPARATOR

Patients will take an inert tablet similar in appearance, color and consistency

Drug: Placebo Oral Tablet

Interventions

Esomeprazole 40 mg Oral TabletDRUG

once daily oral tablets

Also known as: Nexium
study group
Placebo Oral TabletDRUG

once daily oral tablets

Also known as: inert
control group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Gestational age between 28 + 0 weeks and 31 + 6 weeks
  • Estimated fetal weight by ultrasound between 500 gm and 1800 gm (if gestation is not certain).
  • Singleton pregnancy.
  • The patient will be managed with expectant management.

You may not qualify if:

  • Patient is unable or unwilling to give consent
  • Established fetal compromise that necessitates delivery.
  • The presence of any of the following at presentation:
  • Eclampsia.
  • Severe hypertension.
  • Cerebrovascular event as an ischaemic or haemorrhagic stroke.
  • Renal impairment.
  • Signs of left ventricular failure which include pulmonary oedema.
  • Disseminated intravascular coagulation (DIC)
  • Haemolysis, elevated liver enzymes and low platelets (HELLP syndrome)
  • Fetal distress on cardiotocography
  • Contra-indications for expectant management of pre-eclampsia
  • Current use of a proton pump inhibitor
  • Contraindications to the use of a proton pump inhibitor
  • Previous hypersensitivity reaction to a proton pump inhibitor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut Faculty of Medicine

Asyut, Egypt

Location

Related Publications (3)

  • Cluver CA, Walker SP, Mol BW, Theron GB, Hall DR, Hiscock R, Hannan N, Tong S. Double blind, randomised, placebo-controlled trial to evaluate the efficacy of esomeprazole to treat early onset pre-eclampsia (PIE Trial): a study protocol. BMJ Open. 2015 Oct 28;5(10):e008211. doi: 10.1136/bmjopen-2015-008211.

    PMID: 26510725BACKGROUND

  • Lagana AS, Favilli A, Triolo O, Granese R, Gerli S. Early serum markers of pre-eclampsia: are we stepping forward? J Matern Fetal Neonatal Med. 2016 Sep;29(18):3019-23. doi: 10.3109/14767058.2015.1113522. Epub 2015 Nov 23.

    PMID: 26512423BACKGROUND

  • Baumann MU, Bersinger NA, Mohaupt MG, Raio L, Gerber S, Surbek DV. First-trimester serum levels of soluble endoglin and soluble fms-like tyrosine kinase-1 as first-trimester markers for late-onset preeclampsia. Am J Obstet Gynecol. 2008 Sep;199(3):266.e1-6. doi: 10.1016/j.ajog.2008.06.069.

    PMID: 18771978BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

EsomeprazoleTabletsNoble Gases

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDosage FormsPharmaceutical PreparationsElementsInorganic ChemicalsGases

Study Officials

  • Ahmed Abbas, MD

    Assiut University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 8, 2017

First Posted

July 11, 2017

Study Start

March 15, 2018

Primary Completion

July 1, 2020

Study Completion

October 15, 2020

Last Updated

January 7, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)