Preterm LaborNCT05828966
HUMAN CHORIONIC GONADOTROPIN (HcG) VS MAGNESIUM SULPHATE (MgSo4) AS A TOCOLYTIC AGENT- A RANDOMIZED CONTROLLED TRIAL
A study testing human chorionic gonadotropin (hCG) and Magnesium sulfate in people with Preterm Labor, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
Trial summary
Preterm labor is defined as regular contractions of the uterus resulting in changes in the cervix (effacement and dilatation) that start before 37 weeks of pregnancy. (1) Although preterm labor constitutes only 10% of total labors, yet 70% of infant's mortality is related to prematurity. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Preterm Labor
- What is being tested?
- human chorionic gonadotropin (hCG) and Magnesium sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Feb 2023to 20 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 4 uterine contractions per 20 min or 8 contractions per hour
- single live fetus
- Pregnancy less than 37 weeks
- Intact Membranes,
- Dilatation less than 3cm and effacement less than 80%.
Who cannot join
- Cervical Dilatation more than 4 cm
- Abnormal vaginal bleeding
- Premature Rupture of membranes
- Cardiopulmonary compromised
- Fetal and Uterine anomalies
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Mother and Child Care Hospital, Shaheed Zulfiqar Ali Bhutto Medical University
Islamabad, 44000
About this study
Preterm labor is defined as regular contractions of the uterus resulting in changes in the cervix (effacement and dilatation) that start before 37 weeks of pregnancy. (1) Although preterm labor constitutes only 10% of total labors, yet 70% of infant's mortality is related to prematurity. It is therefore one of the international indices in assessment of health condition worldwide. Human Chorionic Gonadotropin (H.C.G.) is a heterodimeric glycoprotein produced primarily in the placenta and has multiple endocrines, paracrine and immunoregulatory actions. (3) The importance of H.C.G. in maintenance of early pregnancy has been widely accepted, reports have highlighted a potential role of H.C.G. in maintaining uterine quiescence in the third trimester. H.C.G. exerts a potent concentration dependent inhibitory effect on human myometrial contractions. (4) Recent data suggests that H.C.G. might have a role as an endogenous tocolytic agent in normal pregnancy. A significant decrease in serum H.C.G. level was found 2-3 weeks before the spontaneous onset of labour. This might contribute to increasing the contractility in the uterine muscle and gradually initiating the onset of labour. (5)
Read the detailed description
Preterm labor is defined as regular contractions of the uterus resulting in changes in the cervix (effacement and dilatation) that start before 37 weeks of pregnancy. (1) Although preterm labor constitutes only 10% of total labors, yet 70% of infant's mortality is related to prematurity. It is therefore one of the international indices in assessment of health condition worldwide. Factors that increase the risk of preterm birth include history of previous preterm birth, short cervix, short time between pregnancies, teenage pregnancy, history of certain types of surgery on the uterus or cervix, certain pregnancy complications, such as multiple pregnancy and vaginal bleeding and lifestyle factors such as low pre-pregnancy weight, smoking during pregnancy, and substance abuse during pregnancy.
Preterm labor can be diagnosed clinically only when changes in the cervix are found after pelvic examination along with contractions also may be monitored. A transvaginal ultrasound exam may be done to measure the length of your cervix. Tocolytics are drugs used to delay delivery for a short time (up to 48 hours). They may allow time for corticosteroids or magnesium sulfate to be given or for you to be transferred to a hospital that offers specialized care for preterm infants. (1,2) Tocolytic agents are β- HCG, MgSO4, nifedipine, β-agonists(salbutamol) and atosiban. Use of salbutamol is of limited use because of many cardiovascular complications i.e., ventricular arrythmia, hypertension and hyperglycemia while atosiban is expensive and not available in Pakistan.
Human Chorionic Gonadotropin (H.C.G.) is a heterodimeric glycoprotein produced primarily in the placenta and has multiple endocrines, paracrine and immunoregulatory actions. (3) The importance of H.C.G. in maintenance of early pregnancy has been widely accepted, reports have highlighted a potential role of H.C.G. in maintaining uterine quiescence in the third trimester. H.C.G. exerts a potent concentration dependent inhibitory effect on human myometrial contractions. (4) Recent data suggests that H.C.G. might have a role as an endogenous tocolytic agent in normal pregnancy. A significant decrease in serum H.C.G. level was found 2-3 weeks before the spontaneous onset of labour. This might contribute to increasing the contractility in the uterine muscle and gradually initiating the onset of labour. (5) Following I.M. injection, peak concentration of H.C.G. occurs about 6 hrs after a dose. It is distributed primarily to gonads. Blood concentration declines in a biphasic manner, with a half-life between about 6 and 11 hrs and 23 to 38 hrs respectively. About 10 to 12% of an IM dose is excreted in urine within 24 hours. (6)
- Conditions
- Preterm Labor
- Being tested
- human chorionic gonadotropin (hCG), Magnesium sulfate
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human chorionic gonadotropin (hCG)Drug
H.C.G. will be given in Group A and in a dose of 5000units intramuscular injection followed by a drip of 10,000 units in 500ml of dextrose 5%, at the rate of 20 drops per minute.
Magnesium sulfateDrug
4gm of MgSO4 will be given in Group B as intravenously as continuous dose followed by 2gm/hr till uterine quiescence is achieved.
| Study group | Role | What they receive |
|---|---|---|
| HUMAN CHORIONIC GONADOTROPIN (HCG) Group | Active comparator | H.C.G. will be given in Group A and in a dose of 5000units intramuscular injection followed by a drip of 10,000 units in 500ml of dextrose 5%, at the rate of 20 drops per minute. Half hourly assessment of uterine contractions, maternal vital signs, fetal heart rate monitoring will be done. Receives: Drug: human chorionic gonadotropin (hCG) |
| Magnesium Sulphate(MgSO4) Group | Active comparator | 4gm of MgSO4 will be given in Group B as intravenously as continuous dose followed by 2gm/hr till uterine quiescence is achieved. Receives: Drug: Magnesium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tocolysis
Tocolysis will be considered successful when contractions ceased and delivery will be delayed by 48 hrs giving time to the administered corticosteroids to accelerate fetal lung maturation
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start15 Feb 2023
- Primary completion15 May 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hafiza Faiza Mushtaq, Shaheed Zulfiqar Ali Bhutto Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828966
- Sponsor's protocol ID
- 001
- Status last verified
- Jun 2024
- First submitted
- 13 Apr 2023
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I have not decided yet .
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HUMAN CHORIONIC GONADOTROPIN (HcG) VS MAGNESIUM SULPHATE (MgSo4) AS A TOCOLYTIC AGENT- A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT05828966
- Acronym / sponsor ID
- 001
- Conditions
- Preterm Labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 25 Apr 2023 (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.
Preterm labor is defined as regular contractions of the uterus resulting in changes in the cervix (effacement and dilatation) that start before 37 weeks of pregnancy. (1) Although preterm labor constitutes only 10% of total labors, yet 70% of infant's mortality is related to prematurity. It is therefore one of the international indices in assessment of health condition worldwide. Human Chorionic Gonadotropin (H.C.G.) is a heterodimeric glycoprotein produced primarily in the placenta and has multiple endocrines, paracrine and immunoregulatory actions. (3) The importance of H.C.G. in maintenance of early pregnancy has been widely accepted, reports have highlighted a potential role of H.C.G. in maintaining uterine quiescence in the third trimester. H.C.G. exerts a potent concentration dependent inhibitory effect on human myometrial contractions. (4) Recent data suggests that H.C.G. might have a role as an endogenous tocolytic agent in normal pregnancy. A significant decrease in serum H.C.G. level was found 2-3 weeks before the spontaneous onset of labour. This might contribute to increasing the contractility in the uterine muscle and gradually initiating the onset of labour. (5)
Detailed description
Preterm labor is defined as regular contractions of the uterus resulting in changes in the cervix (effacement and dilatation) that start before 37 weeks of pregnancy. (1) Although preterm labor constitutes only 10% of total labors, yet 70% of infant's mortality is related to prematurity. It is therefore one of the international indices in assessment of health condition worldwide. Factors that increase the risk of preterm birth include history of previous preterm birth, short cervix, short time between pregnancies, teenage pregnancy, history of certain types of surgery on the uterus or cervix, certain pregnancy complications, such as multiple pregnancy and vaginal bleeding and lifestyle factors such as low pre-pregnancy weight, smoking during pregnancy, and substance abuse during pregnancy.
Preterm labor can be diagnosed clinically only when changes in the cervix are found after pelvic examination along with contractions also may be monitored. A transvaginal ultrasound exam may be done to measure the length of your cervix. Tocolytics are drugs used to delay delivery for a short time (up to 48 hours). They may allow time for corticosteroids or magnesium sulfate to be given or for you to be transferred to a hospital that offers specialized care for preterm infants. (1,2) Tocolytic agents are β- HCG, MgSO4, nifedipine, β-agonists(salbutamol) and atosiban. Use of salbutamol is of limited use because of many cardiovascular complications i.e., ventricular arrythmia, hypertension and hyperglycemia while atosiban is expensive and not available in Pakistan.
Human Chorionic Gonadotropin (H.C.G.) is a heterodimeric glycoprotein produced primarily in the placenta and has multiple endocrines, paracrine and immunoregulatory actions. (3) The importance of H.C.G. in maintenance of early pregnancy has been widely accepted, reports have highlighted a potential role of H.C.G. in maintaining uterine quiescence in the third trimester. H.C.G. exerts a potent concentration dependent inhibitory effect on human myometrial contractions. (4) Recent data suggests that H.C.G. might have a role as an endogenous tocolytic agent in normal pregnancy. A significant decrease in serum H.C.G. level was found 2-3 weeks before the spontaneous onset of labour. This might contribute to increasing the contractility in the uterine muscle and gradually initiating the onset of labour. (5) Following I.M. injection, peak concentration of H.C.G. occurs about 6 hrs after a dose. It is distributed primarily to gonads. Blood concentration declines in a biphasic manner, with a half-life between about 6 and 11 hrs and 23 to 38 hrs respectively. About 10 to 12% of an IM dose is excreted in urine within 24 hours. (6)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HUMAN CHORIONIC GONADOTROPIN (HCG) Group | Active comparator | Drug: human chorionic gonadotropin (hCG)H.C.G. will be given in Group A and in a dose of 5000units intramuscular injection followed by a drip of 10,000 units in 500ml of dextrose 5%, at the rate of 20 drops per minute. Half hourly assessment of uterine contractions, maternal vital signs, fetal heart rate monitoring will be done. |
| Magnesium Sulphate(MgSO4) Group | Active comparator | Drug: Magnesium sulfate4gm of MgSO4 will be given in Group B as intravenously as continuous dose followed by 2gm/hr till uterine quiescence is achieved. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 4 uterine contractions per 20 min or 8 contractions per hour
- single live fetus
- Pregnancy less than 37 weeks
- Intact Membranes,
- Dilatation less than 3cm and effacement less than 80%.
Key exclusion criteria (5 listed)
- Cervical Dilatation more than 4 cm
- Abnormal vaginal bleeding
- Premature Rupture of membranes
- Cardiopulmonary compromised
- Fetal and Uterine anomalies
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 |
|---|---|---|
| human chorionic gonadotropin (hCG)H.C.G. will be given in Group A and in a dose of 5000units intramuscular injection followed by a drip of 10,000 units in 500ml of dextrose 5%, at the rate of 20 drops per minute. | Drug | HUMAN CHORIONIC GONADOTROPIN (HCG) Group |
| Magnesium sulfate4gm of MgSO4 will be given in Group B as intravenously as continuous dose followed by 2gm/hr till uterine quiescence is achieved. | Drug | Magnesium Sulphate(MgSO4) Group |
Primary outcome
Tocolysis
Time frame: 48 hours
Tocolysis will be considered successful when contractions ceased and delivery will be delayed by 48 hrs giving time to the administered corticosteroids to accelerate fetal lung maturation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: Undecided. I have not decided yet .
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing human chorionic gonadotropin (hCG) and Magnesium sulfate in people with Preterm Labor, run by Shaheed Zulfiqar Ali Bhutto Medical University 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: finished, as of the sponsor's last update on 7 Jun 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tocolysis (time frame: 48 hours). 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 7 Jun 2024.