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RecruitingNCT07907731Updated Oct 30, 2026

Effect of LMWH on Neonatal Outcomes in Isolated Oligohydramnios

A Phase 4 interventional study of Enoxaparin (LMWH) and Dextrose Water in Oligohydramnios, Heparin and Neonatal Outcomes, sponsored by PAEC General Hospital, Islamabad. Recruiting at 1 site in Pakistan. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by PAEC General Hospital, Islamabad · Phase 4, Interventional, and Treatment

Updated Oct 30, 2026Newly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Female
01

Study summary

The pregnant women who meet the study requirements will be included in the study. They will be randomly assigned to receive either the usual treatment or the usual treatment along with an additional medicine.

The usual treatment will include fluids given through a vein, rest while lying on the left side, and a low-dose aspirin tablet (75 mg once daily) from the 22nd to the 34th week of pregnancy. Women will also receive 1,000 ml of 5% dextrose fluid daily through a vein, from the time low amniotic fluid is diagnosed until the 36th week of pregnancy.

Some women will also receive an additional injection of a blood-thinning medicine called low-molecular-weight heparin (LMWH), at a dose of 40 mg under the skin, from the 22nd to the 36th week of pregnancy.

All participants will undergo weekly ultrasound examinations to measure the fluid surrounding the baby and assess blood flow through the umbilical cord. The study will record the number of babies born before 37 weeks of pregnancy, the babies' birth weights, and the number of babies born alive.

Read the detailed description

Study Methodology

Pregnant women meeting the eligibility criteria will be enrolled following ethical approval and randomly assigned to receive either conventional treatment alone or conventional treatment in combination with low-molecular-weight heparin (LMWH).

Conventional treatment will consist of left lateral positional rest, intravenous administration of 1,000 mL of 5% dextrose solution daily from the diagnosis of isolated oligohydramnios until 36 weeks of gestation, and oral aspirin at a dose of 75 mg once daily from 22 to 34 weeks of gestation.

In addition to conventional treatment, participants assigned to the intervention will receive subcutaneous LMWH at a dose of 40 mg from 22 to 36 weeks of gestation.

All participants will undergo weekly ultrasonographic assessment of the amniotic fluid index (AFI) and umbilical artery Doppler studies. The primary study outcomes will include the incidence of preterm birth before 37 completed weeks of gestation, neonatal birth weight, and live birth rate.

Clarify the Randomization and Treatment Groups Separate Primary and Secondary Outcomes

02

Conditions studied

  • Oligohydramnios
  • Heparin
  • Neonatal Outcomes

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03

In context

Oligohydramnios

25 studies on the registry are indexed under Oligohydramnios; 5 are open to participants now.

This study's planned enrollment of 106 is above the median of 91 across 16 interventional studies indexed under Oligohydramnios.

Browse Oligohydramnios studies →

Lead sponsor

PAEC General Hospital, Islamabad is the lead sponsor of 9 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Pregnant patients at in second and third trimester.
  2. Isolated oligohydramnios with AFI \< 8 cm
  3. Singelton pregnancy
  4. Intact membranes

Exclusion criteria

Exclusion Criteria:

  1. Hypertension
  2. Diabetes
  3. Fetal abnormalities
  4. Who were already on any treatment for oligohydramnios
  5. Patient having premature pre term rupture of membranes
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
106 participants (estimated)

Study arms

  • Experimental
    Group Enoxaparin

    Drug: Enoxaparin (LMWH)

  • Active comparator
    Group Control

    Drug: Dextrose Water

Interventions

  • Participants will receive conventional treatment, including left lateral positional rest, intravenous 1,000 mL of 5% dextrose daily until 36 weeks of gestation, and oral aspirin 75 mg once daily from 22 to 34 weeks. Additionally, subcutaneous low-molecular-weight heparin (LMWH) 40 mg will be administered from 22 to 36 weeks of gestation.

  • DrugDextrose Water

    Participants will receive conventional treatment, including left lateral positional rest, intravenous 1,000 mL of 5% dextrose daily until 36 weeks of gestation, and oral aspirin 75 mg once daily from 22 to 34 weeks of gestation, without LMWH.

06

What researchers measure

Primary outcomes

  1. Live birth rate

    Time frame: At the time of delivery.

Secondary outcomes

  1. Incidence of Preterm Birth

    Time frame: At the time of delivery.

  2. Mean Birth weight

    Time frame: At the time of delivery.

07

Study locations

1 of 1 sites recruiting
  • Pakistan Atomic Energy Commission General Hospital
    Islamabad, Federal 44000, Pakistan
    Recruiting
08

References and documents

Publications

  • Zaman Z, Imran F, Iqbal MJ. Role of enoxaparin to improve obstetrical outcome in patients with IUGR and oligohydramnios. J Soc Obstet Gynaecol Pak. 2018;8(4):232-237.

Individual participant data

Plan to share: No — Hospital Ethical Committee doesn't allow IPD sharing

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2026 (actual). Primary completion is estimated for Jan 2027, 3 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 24, 2026
First posted
Oct 30, 2026
StartActual
Oct 24, 2026
Primary completionEst.
Jan 25, 2027
CompletionEst.
Jan 30, 2027
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07907731
Lead sponsor
PAEC General Hospital, Islamabad
Responsible party
Mehtab Aslam (Principal Investigator, PAEC General Hospital, Islamabad) — Principal investigator
First posted
Oct 30, 2026
Start date
Oct 24, 2026
Primary completion
Jan 25, 2027 (estimated)
Completion
Jan 30, 2027 (estimated)
Last update
Oct 30, 2026

Study contacts

Mehtab Aslam, MBBS
Contact
mehtabaslam182@gmail.com
+92-332-8441418

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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