NCT07462182

Brief Summary

The local literature lacks comprehensive information regarding the actual incidence of intrauterine growth restriction (IUGR) and oligohydramnios and currently available therapeutic options. Therefore, the current study was planned with the objective to evaluate the impact of enoxaparin therapy compared with standard management on neonatal outcomes in pregnancies complicated by intrauterine growth restriction (IUGR) with oligohydramnios.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress29%
Apr 2026Sep 2026

First Submitted

Initial submission to the registry

March 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 4, 2026

Last Update Submit

March 4, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Live birth

    The frequency of live birth will be noted. Delivery of a baby with signs of life at birth, irrespective of gestational age will be considered as live birth.

    12 weeks

  • Low Birth weight

    Frequency of low birth weight will be noted. Neonatal birth weight \<2.5 kg will be documented as low birth weight.

    12 weeks

Secondary Outcomes (2)

  • Neonatal Intensive Care Unit Admission

    7 days

  • Perinatal Mortality

    7 days

Study Arms (2)

Enoxaparin Group

EXPERIMENTAL

Patients will receive standard management plus enoxaparin 40 mg subcutaneously once daily until delivery.

Drug: EnoxaparinOther: Standard Management

Standard Management Group

EXPERIMENTAL

Patients will continue with standard management alone.

Other: Standard Management

Interventions

Patients will receive standard management plus enoxaparin 40 mg subcutaneously once daily until delivery

Enoxaparin Group

Patients will continue with standard management alone.

Enoxaparin GroupStandard Management Group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 18-40 years
  • Singleton pregnancy
  • Gestational age ≥28 weeks (confirmed by first-trimester scan or reliable last menstrual period)
  • Diagnosed with both IUGR and oligohydramnios
  • Willing to provide informed written consent

You may not qualify if:

  • Multiple gestation
  • Major fetal congenital anomalies
  • Maternal medical disorders affecting pregnancy outcome (e.g., uncontrolled diabetes, chronic hypertension, renal disease)
  • Known coagulation disorders or contraindications to enoxaparin
  • Women already on anticoagulation therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Combined Military Hospital

Quetta, Balochistan, 80000, Pakistan

Location

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Maimoona Hafeez

    Combined Military Hospital Quetta

    PRINCIPAL INVESTIGATOR
  • Sidra Iqbal, FCPS

    Combined Military Hospital Quetta

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Consultant

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 10, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Data can be shared on a reasonable request.

Locations