PreeclampsiaPhase 4NCT03237000
Effect of Administering Intravenous Magnesium Sulfate on Fetal Cardiotocography and Neonatal Outcome in Preeclamptic Patients
A Phase 4 study testing MgSO4 in people with Preeclampsia, run by Cairo University at 1 site in Egypt.
Trial summary
Admission CTG for 20 minutes Settings on a CTG machine was standardised to enable a consistent approach of interpretation of traces. Paper speed of 3cm per minute will be adopted. Maternal heart rate was recorded and noted on CTG. Following birth date, time and mode of delivery will be labelled on CTG. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- MgSO4
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2017to Jan 2018
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant Women in the third trimester.
- Severely preeclamptic patients.
- Singleton Pregnancy.
- Patients with normal admission CTG
Who cannot join
- Evidence of fetal anomalies on scan.
- Concomitant maternal morbidities as diabetes, cardiac disease.
- Patients contraindicated to take MgSo4 e.g.: advanced renal disease.
- Abnormal admission CTG.
- Morbid obesity.
Trial locations and contacts
1 site in 1 country.
Ahmed Ibrahim, MD contact
About this study
Official title: Effect of Administering Intravenous Magnesium Sulfate Heptahydrate (MgSO4•7H2O) on Fetal Cardiotocography and Neonatal Outcome in Preeclamptic Patients in 3rd Trimester of Pregnancy
Admission CTG for 20 minutes Settings on a CTG machine was standardised to enable a consistent approach of interpretation of traces. Paper speed of 3cm per minute will be adopted. Maternal heart rate was recorded and noted on CTG. Following birth date, time and mode of delivery will be labelled on CTG.
Magnesium sulphate was administered by continuous intravenous infusion according to our hospital protocol as follows:
Read more
- Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered over 15-20 min.
- Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after delivery.
Another 20 minutes CTG strip will be performed 20 minutes after administration of IV loading MgSO4, 7H2O and thus ensuring that MgSO4 has reached peak serum levels
Read the detailed description
Admission CTG:
Admission CTG will be performed for 20 minutes
I-Settings:
- Settings on a CTG machine will be standardised to enable a consistent approach of interpretation of traces.
- Paper speed of 3cm per minute will be adopted.
- CTGs will be labelled with mother's name, hospital number.
- Date and time settings on machines will be labelled at commencement of tracing.
- Maternal heart rate will be recorded and noted on CTG.
- Following birth date, time and mode of delivery will be labelled on CTG.
Magnesium Sulphate hepatahydrate administration:
Magnesium sulphate will be administered by continuous intravenous infusion according to our hospital protocol as follows:
- Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered over 15-20 min.
- Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after delivery.
- Magnesium toxicity was monitored by hourly assessment of:
- Patellar reflexes should be present.
- Respiratory rate not < 16/min.
- Urine output not < 100ml / hr. Another 20 minutes CTG strip will be performed 20 minutes after administration of IV loading MgSO4, 7H2O and thus ensuring that MgSO4 has reached peak serum levels
- Conditions
- Preeclampsia
- Being tested
- MgSO4
- Keywords
- Preeclampsia, MgSO4
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MgSO4Drug
Also called Magnisium sulfate
Magnesium sulphate was administered by continuous intravenous infusion according to our hospital protocol as follows:
- Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered over 15-20 min.
- Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after delivery.
| Study group | Role | What they receive |
|---|---|---|
| MgSO4 | Experimental | Magnesium sulphate was administered by continuous intravenous infusion according to our hospital protocol as follows:
* Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered over 15-20 min.
* Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after delivery. Receives: Drug: MgSO4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal heart rate tracing
Settings on a CTG machine is standardised to enable a consistent approach of interpretation of traces. Paper speed of 3cm per minute is adopted
Measured: 20 minutes after MgSO4 administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start1 Aug 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Magnesium sulphate was administered by continuous intravenous infusion according to our hospital protocol as follows: * Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered over 15-20 min. * Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after delivery.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, kasr Alainy medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237000
- Sponsor's protocol ID
- 7
- Status last verified
- Jul 2017
- First submitted
- 31 Jul 2017
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Administering Intravenous Magnesium Sulfate Heptahydrate (MgSO4•7H2O) on Fetal Cardiotocography and Neonatal Outcome in Preeclamptic Patients in 3rd Trimester of Pregnancy
- ClinicalTrials.gov ID
- NCT03237000
- Acronym / sponsor ID
- 7
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, MgSO4
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 2 Aug 2017 (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.
Admission CTG for 20 minutes Settings on a CTG machine was standardised to enable a consistent approach of interpretation of traces. Paper speed of 3cm per minute will be adopted. Maternal heart rate was recorded and noted on CTG. Following birth date, time and mode of delivery will be labelled on CTG.
Magnesium sulphate was administered by continuous intravenous infusion according to our hospital protocol as follows:
- Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered over 15-20 min.
- Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after delivery.
Another 20 minutes CTG strip will be performed 20 minutes after administration of IV loading MgSO4, 7H2O and thus ensuring that MgSO4 has reached peak serum levels
Detailed description
Admission CTG:
Admission CTG will be performed for 20 minutes
I-Settings:
- Settings on a CTG machine will be standardised to enable a consistent approach of interpretation of traces.
- Paper speed of 3cm per minute will be adopted.
- CTGs will be labelled with mother's name, hospital number.
- Date and time settings on machines will be labelled at commencement of tracing.
- Maternal heart rate will be recorded and noted on CTG.
- Following birth date, time and mode of delivery will be labelled on CTG.
Magnesium Sulphate hepatahydrate administration:
Magnesium sulphate will be administered by continuous intravenous infusion according to our hospital protocol as follows:
- Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered over 15-20 min.
- Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after delivery.
- Magnesium toxicity was monitored by hourly assessment of:
- Patellar reflexes should be present.
- Respiratory rate not < 16/min.
- Urine output not < 100ml / hr. Another 20 minutes CTG strip will be performed 20 minutes after administration of IV loading MgSO4, 7H2O and thus ensuring that MgSO4 has reached peak serum levels
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Magnesium sulphate was administered by continuous intravenous infusion according to our hospital protocol as follows: * Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered over 15-20 min. * Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after delivery.
| Arm | Type | Receives |
|---|---|---|
| MgSO4 | Experimental | Drug: MgSO4Magnesium sulphate was administered by continuous intravenous infusion according to our hospital protocol as follows: * Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered over 15-20 min. * Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after delivery. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant Women in the third trimester.
- Severely preeclamptic patients.
- Singleton Pregnancy.
- Patients with normal admission CTG
Key exclusion criteria (5 listed)
- Evidence of fetal anomalies on scan.
- Concomitant maternal morbidities as diabetes, cardiac disease.
- Patients contraindicated to take MgSo4 e.g.: advanced renal disease.
- Abnormal admission CTG.
- Morbid obesity.
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 |
|---|---|---|
| MgSO4Also: Magnisium sulfateMagnesium sulphate was administered by continuous intravenous infusion according to our hospital protocol as follows: * Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered over 15-20 min. * Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after delivery. | Drug | MgSO4 |
Primary outcome
Fetal heart rate tracing
Time frame: 20 minutes after MgSO4 administration
Settings on a CTG machine is standardised to enable a consistent approach of interpretation of traces. Paper speed of 3cm per minute is adopted
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
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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.
Ahmed Ibrahim, MD contact
Ahmed Maged, MD principal investigator
kasr Alainy medical school
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 MgSO4 in people with Preeclampsia, run by Cairo 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 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: status not confirmed, as of the sponsor's last update on 2 Aug 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Maged, MD (01005227404, prof.ahmedmaged@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal heart rate tracing (time frame: 20 minutes after MgSO4 administration). 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 2 Aug 2017.