Metformin for Obese Pregnant WomenPhase 4NCT05554679
Maternal and Fetal Outcome With Metformin Therapy for Obese Pregnant Women .
A Phase 4 study testing Metformin in people with Metformin for Obese Pregnant Women, run by Assiut University at 1 site in Egypt.
Trial summary
To evaluate the role of metformin in pregnant women with obesity (BMI above 30) , on maternal and infant outcome. Read more about this study
- Who is it for?
- Ages 17 to 44 years, women only
- Conditions the study is for
- Metformin for Obese Pregnant Women
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 11 Jul 2023
- Phase
- Phase 4
- 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 17 to 44 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- pregnant women with BMI ≥ 30 kg/m2, and normal glucose tolerance test.
Who cannot join
- pregnant women who are diabetic,
- had a history of previous GDM,
- previous small baby,
- PCO or
- previous early pre-eclampsia,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maternal and Fetal Outcome With Metformin Therapy for Obese Pregnant Women a Randomized Control Trial.
To evaluate the role of metformin in pregnant women with obesity (BMI above 30) , on maternal and infant outcome.
Read the detailed description
Obesity is defined as having an excessive amount of body fat based on the BMI, Obesity can be classified based on the BMI to obese class I ,Class II ,and extreme obesity (class III) , Obesity can harm the fertility by inhibiting normal ovulation. Even in women who regularly ovulate, the greater the BMI, the longer it appears to take to become pregnant. Obesity can also affect the outcome of in vitro fertilization (IVF). (1)
Being obese during pregnancy increases the risk of various pregnancy complications, including :
Miscarriage ,stillbirth ,GD , preeclampsia , obstructive sleep apnea , difficult vaginal delivery ,need for C-section ,and complication of C-section ,Fetal macrosomia , and increasing the risk for metabolic syndrome and childhood obesity , it also make It may be hard for the participants health care provider to diagnose birth defects during pregnancy even prenatal tests like ultrasound(2),(3) .
Normal weight gain during pregnancy for obese women having single pregnancy is between about (5-9) KG .
Normal weight gain during pregnancy for obese women having Multiple pregnancy is between about (11-19) KG (4).
For women who are extremely obese, gaining less than the recommended amount or losing weight during pregnancy might lower the risk of fetal and neonatal macrosomia .
The fetus is regarded as suspected appropriate or gestational age (AGA) when the Sonographic Estimated Fetal Weight (SEFW) is at 10th to 90th percentile for gestational age (GA), and suspected LGA when the SEFW > 90th percentile (5) .
A baby diagnosed with fetal macrosomia has a birth weight of more than 8 pounds,(4,000 grams), regardless of his or her gestational age (6,7,8) .
In this study the investigator will try to focus on diagnose undiagnosed diabetic using GTT (glucose tolerance test specially with women who has one or more risk factors A raised body mass index (BMI) over 30kg/m². A previous baby over 4kg or more ,Confirmed gestational diabetes in a previous pregnancy or have a first degree relative that has diabetes All pregnant women who have not already been diagnosed with diabetes should be screened for Diabetes with a fasting plasma glucose (FPG), an HbA1c, or an untimed random plasma glucose test at their first prenatal visit
- Women who by 24 weeks' gestation have not yet been diagnosed with overt or gestational diabetes should, at between 24 and 28 weeks' gestation, undergo a 2-hour, 75-g OGTT for gestational diabetes
- At 24-28 weeks' gestation, a result of 153-199 mg/dL for a 2-hour, 75-g OGTT indicates gestational diabetes, while a test result of 200 mg/dL or higher indicates overt diabetes(9),(10)
- Conditions
- Metformin for Obese Pregnant Women
- Being tested
- Metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Metformin is an oral insulin-sensitising medication that acts to decrease blood glucose concentrations. It inhibits pathways in the liver that stimulate glucose production and also acts to increase glucose uptake into skeletal muscle and fat cells . Metformin is commonly used in the treatment of type 2 diabetes mellitus and polycystic ovarian syndrome , and is being used increasingly in the treatment of gestational diabetes, having been shown to result in decreased rates of neonatal hypoglycaemia and no increased risk of adverse maternal outcomes when compared with insulin.
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | obese pregnant women who take metformin Receives: Drug: Metformin |
| group B | No intervention | obese pregnant women who take no metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal birth weight
The fetus is regarded as suspected appropriate for gestational age (AGA) when the Sonographic Estimated Fetal Weight (SEFW) is at 10th to 90th percentile for gestational age (GA), and suspected LGA when the SEFW > 90th percentile ,A baby diagnosed with fetal macrosomia has a birth weight of more than 8 pounds,(4,000 grams), regardless of his or her gestational age.
Measured: Baseline
Secondary outcomes (1)
Maternal weight gain
Health care providers who care for pregnant women should determine a woman's body mass index at the initial prenatal visit and counsel her regarding the benefits of appropriate weight gain, nutrition and exercise, and, especially, the need to limit excessive weight gain to achieve best pregnancy outcome . for women of normal weight, 14.1-22.7 kg (31-50 lb) for overweight women, and 11.3-19.1 kg (25-42 lb) for obese women
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start1 Feb 2021
- Primary completion30 Dec 2022
- Study completion11 Jul 2023
Why it stopped: financial issues
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 Metformin for Obese Pregnant WomenStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- metformin effect on prevention of macrosomia in obese pregnant women
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Ibram Samy, Assiut University
- Investigators
- Ahmed Abuelhasan, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554679
- Sponsor's protocol ID
- Metformin in preganancy
- Status last verified
- Feb 2024
- First submitted
- 20 Mar 2020
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hyer S, Balani J, Shehata H. Metformin in Pregnancy: Mechanisms and Clinical Applications. Int J Mol Sci. 2018 Jul 4;19(7):1954. doi: 10.3390/ijms19071954.
PubMed 29973490
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal and Fetal Outcome With Metformin Therapy for Obese Pregnant Women a Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT05554679
- Acronym / sponsor ID
- Metformin in preganancy
- Conditions
- Metformin for Obese Pregnant Women
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: financial issues
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 11 Jul 2023 (actual)
- First posted
- 26 Sep 2022 (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.
To evaluate the role of metformin in pregnant women with obesity (BMI above 30) , on maternal and infant outcome.
Detailed description
Obesity is defined as having an excessive amount of body fat based on the BMI, Obesity can be classified based on the BMI to obese class I ,Class II ,and extreme obesity (class III) , Obesity can harm the fertility by inhibiting normal ovulation. Even in women who regularly ovulate, the greater the BMI, the longer it appears to take to become pregnant. Obesity can also affect the outcome of in vitro fertilization (IVF). (1)
Being obese during pregnancy increases the risk of various pregnancy complications, including :
Miscarriage ,stillbirth ,GD , preeclampsia , obstructive sleep apnea , difficult vaginal delivery ,need for C-section ,and complication of C-section ,Fetal macrosomia , and increasing the risk for metabolic syndrome and childhood obesity , it also make It may be hard for the participants health care provider to diagnose birth defects during pregnancy even prenatal tests like ultrasound(2),(3) .
Normal weight gain during pregnancy for obese women having single pregnancy is between about (5-9) KG .
Normal weight gain during pregnancy for obese women having Multiple pregnancy is between about (11-19) KG (4).
For women who are extremely obese, gaining less than the recommended amount or losing weight during pregnancy might lower the risk of fetal and neonatal macrosomia .
The fetus is regarded as suspected appropriate or gestational age (AGA) when the Sonographic Estimated Fetal Weight (SEFW) is at 10th to 90th percentile for gestational age (GA), and suspected LGA when the SEFW > 90th percentile (5) .
A baby diagnosed with fetal macrosomia has a birth weight of more than 8 pounds,(4,000 grams), regardless of his or her gestational age (6,7,8) .
In this study the investigator will try to focus on diagnose undiagnosed diabetic using GTT (glucose tolerance test specially with women who has one or more risk factors A raised body mass index (BMI) over 30kg/m². A previous baby over 4kg or more ,Confirmed gestational diabetes in a previous pregnancy or have a first degree relative that has diabetes All pregnant women who have not already been diagnosed with diabetes should be screened for Diabetes with a fasting plasma glucose (FPG), an HbA1c, or an untimed random plasma glucose test at their first prenatal visit
- Women who by 24 weeks' gestation have not yet been diagnosed with overt or gestational diabetes should, at between 24 and 28 weeks' gestation, undergo a 2-hour, 75-g OGTT for gestational diabetes
- At 24-28 weeks' gestation, a result of 153-199 mg/dL for a 2-hour, 75-g OGTT indicates gestational diabetes, while a test result of 200 mg/dL or higher indicates overt diabetes(9),(10)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- metformin effect on prevention of macrosomia in obese pregnant women
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Drug: Metforminobese pregnant women who take metformin |
| group B | No intervention | –obese pregnant women who take no metformin |
Who may qualify
- Ages
- 17 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- pregnant women with BMI ≥ 30 kg/m2, and normal glucose tolerance test.
Key exclusion criteria (5 listed)
- pregnant women who are diabetic,
- had a history of previous GDM,
- previous small baby,
- PCO or
- previous early pre-eclampsia,
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 |
|---|---|---|
| MetforminMetformin is an oral insulin-sensitising medication that acts to decrease blood glucose concentrations. It inhibits pathways in the liver that stimulate glucose production and also acts to increase glucose uptake into skeletal muscle and fat cells . Metformin is commonly used in the treatment of type 2 diabetes mellitus and polycystic ovarian syndrome , and is being used increasingly in the treatment of gestational diabetes, having been shown to result in decreased rates of neonatal hypoglycaemia and no increased risk of adverse maternal outcomes when compared with insulin. | Drug | group A |
Primary outcome
Neonatal birth weight
Time frame: Baseline
The fetus is regarded as suspected appropriate for gestational age (AGA) when the Sonographic Estimated Fetal Weight (SEFW) is at 10th to 90th percentile for gestational age (GA), and suspected LGA when the SEFW > 90th percentile ,A baby diagnosed with fetal macrosomia has a birth weight of more than 8 pounds,(4,000 grams), regardless of his or her gestational age.
1 secondary outcome
Maternal weight gain
Time frame: Baseline
Results and safety
The study was stopped early (reason given: financial issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Background: PubMed 29973490Hyer S, Balani J, Shehata H. Metformin in Pregnancy: Mechanisms and Clinical Applications. Int J Mol Sci. 2018 Jul 4;19(7):1954. doi: 10.3390/ijms19071954.
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.
Ahmed Abuelhasan study director
Assiut University
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 Metformin in people with Metformin for Obese Pregnant Women, run by Assiut University at 1 site in Egypt.
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 1 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: stopped early, as of the sponsor's last update on 13 Feb 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 Egypt. 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?
The study was stopped early (reason given: financial issues). Results are not available in the source record.
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?
Neonatal birth weight (time frame: Baseline). 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 NCT05554679, 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 13 Feb 2024.