Intrauterine Growth RestrictionNCT07462182
Impact of Enoxaparin Therapy on Fetal Outcomes in Intrauterine Growth Restriction
A study testing Enoxaparin and Standard Management in people with Intrauterine Growth Restriction, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial summary
The local literature lacks comprehensive information regarding the actual incidence of intrauterine growth restriction (IUGR) and oligohydramnios and currently available therapeutic options. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Intrauterine Growth Restriction
- What is being tested?
- Enoxaparin and Standard Management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Combined Military Hospital
Quetta, Balochistan, 80000
Maimoona Hafeez, +923135495729, maimoonahafeez777@gmail.com
Sidra Iqbal, PCPS, +923336391038, drsidraiqbal4@gmail.com
About this study
Official title: Impact of Enoxaparin Therapy on Fetal Outcomes in Intrauterine Growth Restriction With Oligohydramnios.
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.
Read the detailed description
The use of enoxaparin is not yet a standard practice in pregnancies with IUGR and oligohydramnios without overt maternal thrombophilia. Given the notable incidence of IUGR and oligohydramnios and the limited therapeutic options currently available, exploring the potential benefits of enoxaparin therapy against standard management is both clinically and socially relevant. By investigating whether enoxaparin can improve fetal outcomes in this high-risk group, the findings of this study would generate evidence that could inform future management protocols, reduce preventable perinatal morbidity and mortality, and ultimately improve neonatal survival and health in Pakistan.
- Conditions
- Intrauterine Growth Restriction
- Being tested
- Enoxaparin, Standard Management
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
Patients will receive standard management plus enoxaparin 40 mg subcutaneously once daily until delivery
Standard ManagementOther
Patients will continue with standard management alone.
| Study group | Role | What they receive |
|---|---|---|
| Enoxaparin Group | Experimental | Patients will receive standard management plus enoxaparin 40 mg subcutaneously once daily until delivery. Receives: Drug: Enoxaparin; Other: Standard Management |
| Standard Management Group | Experimental | Patients will continue with standard management alone. Receives: Other: Standard Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (2)
Neonatal Intensive Care Unit Admission
The frequency of admission to the neonatal intensive care unit will be noted.
Measured: 7 days
Perinatal Mortality
Perinatal mortality will be labeled "yes" if there is a stillbirth or neonatal death within the first 7 days of life.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine Growth RestrictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Maimoona Hafeez, Principal investigator, Combined Military Hospital QuettaSidra Iqbal, FCPS, Study director, Combined Military Hospital Quetta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462182
- Sponsor's protocol ID
- Dr-Maimoona-Quetta
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Enoxaparin Therapy on Fetal Outcomes in Intrauterine Growth Restriction With Oligohydramnios.
- ClinicalTrials.gov ID
- NCT07462182
- Acronym / sponsor ID
- Dr-Maimoona-Quetta
- Conditions
- Intrauterine Growth Restriction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The use of enoxaparin is not yet a standard practice in pregnancies with IUGR and oligohydramnios without overt maternal thrombophilia. Given the notable incidence of IUGR and oligohydramnios and the limited therapeutic options currently available, exploring the potential benefits of enoxaparin therapy against standard management is both clinically and socially relevant. By investigating whether enoxaparin can improve fetal outcomes in this high-risk group, the findings of this study would generate evidence that could inform future management protocols, reduce preventable perinatal morbidity and mortality, and ultimately improve neonatal survival and health in Pakistan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enoxaparin Group | Experimental | Drug: Enoxaparin, Other: Standard ManagementPatients will receive standard management plus enoxaparin 40 mg subcutaneously once daily until delivery. |
| Standard Management Group | Experimental | Other: Standard ManagementPatients will continue with standard management alone. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnoxaparinPatients will receive standard management plus enoxaparin 40 mg subcutaneously once daily until delivery | Drug | Enoxaparin Group |
| Standard ManagementPatients will continue with standard management alone. | Other | Enoxaparin Group, Standard Management Group |
Primary outcome
Live birth
Time frame: 12 weeks
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.
Low Birth weight
Time frame: 12 weeks
Frequency of low birth weight will be noted. Neonatal birth weight <2.5 kg will be documented as low birth weight.
2 secondary outcomes
Neonatal Intensive Care Unit Admission
Time frame: 7 days
Perinatal Mortality
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request.
Related trials for Intrauterine Growth Restriction
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Recruiting
STV Analysis Versus Visual Evaluation of Cardiotocography in FGR
Fetal Growth Retardation
RecruitingPhase 2
Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)
Preeclampsia (PE), Intrauterine Growth Restriction (IUGR)
RecruitingObservational study
Natural History of Craniofacial Anomalies and Developmental Growth Variants
Prognathism, Retrognathism
RecruitingObservational study
Primordial Dwarfism Registry
MOPDII, Meier-Gorlin Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maimoona Hafeez principal investigator
Combined Military Hospital Quetta
Sidra Iqbal, FCPS study director
Combined Military Hospital Quetta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enoxaparin and Standard Management in people with Intrauterine Growth Restriction, run by Muhammad Aamir Latif at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maimoona Hafeez (+923135495729, maimoonahafeez777@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.