OligohydramniosPhase 4NCT07907731
Effect of LMWH on Neonatal Outcomes in Isolated Oligohydramnios
A Phase 4 study testing Enoxaparin (LMWH) and Dextrose Water in people with Oligohydramnios and Heparin, run by PAEC General Hospital, Islamabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Oligohydramnios, Heparin, Neonatal Outcomes
- What is being tested?
- Enoxaparin (LMWH) and Dextrose Water
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Oct 2026to 30 Jan 2027
- Phase
- Phase 4
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant patients at in second and third trimester.
- Isolated oligohydramnios with AFI < 8 cm
- Singelton pregnancy
- Intact membranes
Who cannot join
- Hypertension
- Diabetes
- Fetal abnormalities
- Who were already on any treatment for oligohydramnios
- Patient having premature pre term rupture of membranes
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, 1 recruiting
- Recruiting
Pakistan Atomic Energy Commission General Hospital
Islamabad, Federal, 44000
Ayesha Tariq, MBBS, +92519258862, aaysha1972@hotmail.com
About this study
Official title: Comparison of the Effect of Conventional Method Along With LMWH vs Conventional Method Alone in Improvement of Neonatal Outcomes in Pregnancies Complicated With Isolated Oligohydramnios in 2nd and 3rd Trimester.
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.
Read more
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
- Conditions
- Oligohydramnios, Heparin, Neonatal Outcomes
- Being tested
- Enoxaparin (LMWH), Dextrose Water
- Medical subject headings
- Oligohydramnios
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enoxaparin (LMWH)Drug
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.
Dextrose WaterDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group Enoxaparin | Experimental | Not described Receives: Drug: Enoxaparin (LMWH) |
| Group Control | Active comparator | Not described Receives: Drug: Dextrose Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
Measured: At the time of delivery.
Secondary outcomes (2)
Incidence of Preterm Birth
Measured: At the time of delivery.
Mean Birth weight
Measured: At the time of delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start24 Oct 2026
- Primary completion25 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OligohydramniosStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PAEC General Hospital, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehtab Aslam, PAEC General Hospital, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907731
- Sponsor's protocol ID
- PGH-IRB (DME)-RCD-06-100
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Hospital Ethical Committee doesn't allow IPD sharing
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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Conventional Method Along With LMWH vs Conventional Method Alone in Improvement of Neonatal Outcomes in Pregnancies Complicated With Isolated Oligohydramnios in 2nd and 3rd Trimester.
- ClinicalTrials.gov ID
- NCT07907731
- Acronym / sponsor ID
- PGH-IRB (DME)-RCD-06-100
- Conditions
- Oligohydramnios, Heparin, Neonatal Outcomes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- PAEC General Hospital, IslamabadUniversity, hospital or other
- Study start
- 24 Oct 2026 (actual)
- Primary completion
- 25 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 30 Oct 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 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Enoxaparin | Experimental | Drug: Enoxaparin (LMWH) |
| Group Control | Active comparator | Drug: Dextrose Water |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant patients at in second and third trimester.
- Isolated oligohydramnios with AFI < 8 cm
- Singelton pregnancy
- Intact membranes
Key exclusion criteria (5 listed)
- Hypertension
- Diabetes
- Fetal abnormalities
- Who were already on any treatment for oligohydramnios
- Patient having premature pre term rupture of membranes
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 |
|---|---|---|
| Enoxaparin (LMWH)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. | Drug | Group Enoxaparin |
| Dextrose WaterParticipants 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. | Drug | Group Control |
Primary outcome
Live birth rate
Time frame: At the time of delivery.
2 secondary outcomes
Incidence of Preterm Birth
Time frame: At the time of delivery.
Mean Birth weight
Time frame: At the time of delivery.
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 30 Oct 2026.
- BackgroundZaman 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 dataSharing planned: No. Hospital Ethical Committee doesn't allow IPD sharing
Related trials for Oligohydramnios
RecruitingPhase 3
A Study to See if Tolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)
Autosomal Recessive Polycystic Kidney (ARPKD)
RecruitingObservational study
PPROM Registry (Preterm Premature Rupture of Membranes)
Fetal Membranes, Premature Rupture, Preterm Premature Rupture of the Membranes
Not yet recruiting
Impact of Enoxaparin Therapy on Fetal Outcomes in Intrauterine Growth Restriction
Intrauterine Growth Restriction
Recruiting
"Fetal gRowth AbnorMality dEtection Trial"
Small for Gestational Age Infant, Large for Gestational Age Infant
Active, not recruitingObservational study
Dilapan-S®: A Multicenter US E-registry
Post Term Pregnancy, Premature Rupture of Membrane
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enoxaparin (LMWH) and Dextrose Water in people with Oligohydramnios and Heparin, run by PAEC General Hospital, Islamabad 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 4 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: looking for participants now, as of the sponsor's last update on 30 Oct 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Mehtab Aslam, MBBS (+92-332-8441418, mehtabaslam182@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate (time frame: At the time of delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07907731, which also lists 1 linked publication.
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 30 Oct 2026.