Postpartum PreeclampsiaPhase 4NCT03449277
Oral Nifedipine Versus Labetalol in Treatment of Postpartum Hypertension
A Phase 4 study testing Oral Tablet in people with Postpartum Preeclampsia, run by Hossam Ahmed Abd Ellah at 1 site in Egypt.
Trial summary
Hypertensive disorders of pregnancy are important cause of severe morbidity, long-term disability and death among both mothers and their babies. In Africa and Asia, nearly one tenth of all maternal deaths are associated with hypertensive disorders of pregnancy research has focused on the antenatal complications' for… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Postpartum Preeclampsia
- What is being tested?
- Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Jan 2018to 1 Mar 2019
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who have hypertension during pregnancy and persist after delivery till discharge of hospital about 2 days of monitoring the blood pressure
Who cannot join
- Women with history of secondary hypertension Women with eclampsia who need intensive care unit admission and indicated other drugs rather than oral nifedipine and oral labetalol Women who have any contraindication to Nifedipine or labetalol
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Hossam Ahmed Abd Ellah
Asyut
Hossam Ahmed Abd Ellah, MBBCH, 0201119939775, drhaaada@gmail.com
About this study
Hypertensive disorders of pregnancy are important cause of severe morbidity, long-term disability and death among both mothers and their babies. In Africa and Asia, nearly one tenth of all maternal deaths are associated with hypertensive disorders of pregnancy research has focused on the antenatal complications' for both mother and baby and the risks and benefits of administering antihypertensive therapy prior to delivery hypertension disorders of pregnancy often persist following delivery and sometimes arise de novo postpartum one of the maternal complications of pre eclampsia is residual chronic hypertension in about 1/3 of cases elevated blood pressure is seen in 6%to 8% of all pregnancies hypertension (arterial pressure >140/90 mmhg) in pregnancy is classified into one of four conditions
- chronic hypertension that precedes pregnancy
- pre eclampsia and eclampsia: a systematic syndrome of elevated arterial pressure,proteinuria and other findings
- pre eclampsia superimposed upon chronic hypertension
- gestational hypertension or nonproteinuric hypertension of pregnancy
Read the detailed description
Hypertensive disorders of pregnancy are important cause of severe morbidity, long-term disability and death among both mothers and their babies. In Africa and Asia, nearly one tenth of all maternal deaths are associated with hypertensive disorders of pregnancy research has focused on the antenatal complications' for both mother and baby and the risks and benefits of administering antihypertensive therapy prior to delivery hypertension disorders of pregnancy often persist following delivery and sometimes arise de novo postpartum one of the maternal complications of pre eclampsia is residual chronic hypertension in about 1/3 of cases elevated blood pressure is seen in 6%to 8% of all pregnancies hypertension (arterial pressure >140/90 mmhg) in pregnancy is classified into one of four conditions
- chronic hypertension that precedes pregnancy
- pre eclampsia and eclampsia: a systematic syndrome of elevated arterial pressure,proteinuria and other findings
- pre eclampsia superimposed upon chronic hypertension
- gestational hypertension or nonproteinuric hypertension of pregnancy evaluate the effectiveness, safety and acceptability of Oral nifedipine versus oral labetalol in treatment of persistent postpartum hypertension
- Conditions
- Postpartum Preeclampsia
- Being tested
- Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral TabletDrug
Also called Monitoring blood pressure
oral labetalol tablets and oral nifedipine tablets
| Study group | Role | What they receive |
|---|---|---|
| take oral nifedipine tablets | Active comparator | Women who take the oral tablets of nifedipine till discharge of hospital Receives: Drug: Oral Tablet |
| take oral labetalol tablets | Active comparator | Women who take the oral tablets of labetalol till discharge of hospital Receives: Drug: Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
control blood pressure
duration,total dose to achieve blood pressure below the critical value between 140 and 150 mmHg systolic and 90-100 mmHg diastolic by monitoring of blood pressure
Measured: till discharge of hospital about two days
Secondary outcomes (4)
Resolution of complications
Measured by monitoring of blood pressure and monitoring of the complications
Measured: till discharge of hospital about two days
Improvement of hematological values
By repeated Complete blood count
Measured: till discharge of hospital about two days
Side effects in both groups
Monitoring if there is any side effect of any drug
Measured: till discharge of hospital about two days
Improvement of other investigations
Monitoring by repeated urine analysis,other investigations
Measured: till discharge of hospital about two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start19 Jan 2018
- Primary completion1 Feb 2019 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Postpartum PreeclampsiaStudies 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hossam Ahmed Abd Ellah
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Sponsor-investigator, Hossam Ahmed Abd Ellah, Assiut University
- Investigators
- Mohamed Mahmoud, Prof, Study director, Prof of ob& Gyn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449277
- Sponsor's protocol ID
- U1111-1209-5934
- Status last verified
- Apr 2018
- First submitted
- 19 Feb 2018
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
WHO Recommendations for Prevention and Treatment of Pre-Eclampsia and Eclampsia. Geneva: World Health Organization; 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK140561/
PubMed 23741776Abalos E, Duley L, Steyn DW, Henderson-Smart DJ. Antihypertensive drug therapy for mild to moderate hypertension during pregnancy. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD002252. doi: 10.1002/14651858.CD002252.pub2.
PubMed 17253478Magee L, von Dadelszen P. Prevention and treatment of postpartum hypertension. Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD004351. doi: 10.1002/14651858.CD004351.pub3.
PubMed 23633317Geneva Foundation for Medical Education and Research 2017: hypertensive disorders in pregnancy
ACOG technical bulletin. Hypertension in pregnancy. Number 219--January 1996 (replaces no. 91, February 1986). Committee on Technical Bulletins of the American College of Obstetricians and Gynecologists. Int J Gynaecol Obstet. 1996 May;53(2):175-83. No abstract available.
PubMed 8735301Lenfant C; National Education Program Working Group on High Blood Pressure in Pregnancy. Working group report on high blood pressure in pregnancy. J Clin Hypertens (Greenwich). 2001 Mar-Apr;3(2):75-88. doi: 10.1111/j.1524-6175.2001.00458.x.
PubMed 11416689
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Nifedipine Versus Labetalol in Treatment of Postpartum Hypertension
- ClinicalTrials.gov ID
- NCT03449277
- Acronym / sponsor ID
- U1111-1209-5934
- Conditions
- Postpartum Preeclampsia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hossam Ahmed Abd EllahUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 1 Feb 2019 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 28 Feb 2018 (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.
Hypertensive disorders of pregnancy are important cause of severe morbidity, long-term disability and death among both mothers and their babies. In Africa and Asia, nearly one tenth of all maternal deaths are associated with hypertensive disorders of pregnancy research has focused on the antenatal complications' for both mother and baby and the risks and benefits of administering antihypertensive therapy prior to delivery hypertension disorders of pregnancy often persist following delivery and sometimes arise de novo postpartum one of the maternal complications of pre eclampsia is residual chronic hypertension in about 1/3 of cases elevated blood pressure is seen in 6%to 8% of all pregnancies hypertension (arterial pressure >140/90 mmhg) in pregnancy is classified into one of four conditions
- chronic hypertension that precedes pregnancy
- pre eclampsia and eclampsia: a systematic syndrome of elevated arterial pressure,proteinuria and other findings
- pre eclampsia superimposed upon chronic hypertension
- gestational hypertension or nonproteinuric hypertension of pregnancy
Detailed description
Hypertensive disorders of pregnancy are important cause of severe morbidity, long-term disability and death among both mothers and their babies. In Africa and Asia, nearly one tenth of all maternal deaths are associated with hypertensive disorders of pregnancy research has focused on the antenatal complications' for both mother and baby and the risks and benefits of administering antihypertensive therapy prior to delivery hypertension disorders of pregnancy often persist following delivery and sometimes arise de novo postpartum one of the maternal complications of pre eclampsia is residual chronic hypertension in about 1/3 of cases elevated blood pressure is seen in 6%to 8% of all pregnancies hypertension (arterial pressure >140/90 mmhg) in pregnancy is classified into one of four conditions
- chronic hypertension that precedes pregnancy
- pre eclampsia and eclampsia: a systematic syndrome of elevated arterial pressure,proteinuria and other findings
- pre eclampsia superimposed upon chronic hypertension
- gestational hypertension or nonproteinuric hypertension of pregnancy evaluate the effectiveness, safety and acceptability of Oral nifedipine versus oral labetalol in treatment of persistent postpartum hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| take oral nifedipine tablets | Active comparator | Drug: Oral TabletWomen who take the oral tablets of nifedipine till discharge of hospital |
| take oral labetalol tablets | Active comparator | Drug: Oral TabletWomen who take the oral tablets of labetalol till discharge of hospital |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women who have hypertension during pregnancy and persist after delivery till discharge of hospital about 2 days of monitoring the blood pressure
Key exclusion criteria (1 listed)
- Women with history of secondary hypertension Women with eclampsia who need intensive care unit admission and indicated other drugs rather than oral nifedipine and oral labetalol Women who have any contraindication to Nifedipine or labetalol
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 |
|---|---|---|
| Oral TabletAlso: Monitoring blood pressureoral labetalol tablets and oral nifedipine tablets | Drug | take oral labetalol tablets, take oral nifedipine tablets |
Primary outcome
control blood pressure
Time frame: till discharge of hospital about two days
duration,total dose to achieve blood pressure below the critical value between 140 and 150 mmHg systolic and 90-100 mmHg diastolic by monitoring of blood pressure
4 secondary outcomes
Resolution of complications
Time frame: till discharge of hospital about two days
Improvement of hematological values
Time frame: till discharge of hospital about two days
Side effects in both groups
Time frame: till discharge of hospital about two days
Improvement of other investigations
Time frame: till discharge of hospital about two days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
- Background: PubMed 23741776WHO Recommendations for Prevention and Treatment of Pre-Eclampsia and Eclampsia. Geneva: World Health Organization; 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK140561/
- Background: PubMed 17253478Abalos E, Duley L, Steyn DW, Henderson-Smart DJ. Antihypertensive drug therapy for mild to moderate hypertension during pregnancy. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD002252. doi: 10.1002/14651858.CD002252.pub2.
- Background: PubMed 23633317Magee L, von Dadelszen P. Prevention and treatment of postpartum hypertension. Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD004351. doi: 10.1002/14651858.CD004351.pub3.
- BackgroundGeneva Foundation for Medical Education and Research 2017: hypertensive disorders in pregnancy
- Background: PubMed 8735301ACOG technical bulletin. Hypertension in pregnancy. Number 219--January 1996 (replaces no. 91, February 1986). Committee on Technical Bulletins of the American College of Obstetricians and Gynecologists. Int J Gynaecol Obstet. 1996 May;53(2):175-83. No abstract available.
- Background: PubMed 11416689Lenfant C; National Education Program Working Group on High Blood Pressure in Pregnancy. Working group report on high blood pressure in pregnancy. J Clin Hypertens (Greenwich). 2001 Mar-Apr;3(2):75-88. doi: 10.1111/j.1524-6175.2001.00458.x.
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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.
Mohamed Mahmoud, Prof study director
Prof of ob& Gyn
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 Oral Tablet in people with Postpartum Preeclampsia, run by Hossam Ahmed Abd Ellah 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 1 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 4 Apr 2018. 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 Hossam Ahmed Abd Ellah, MBBCH (0201119939775, drhaaada@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
control blood pressure (time frame: till discharge of hospital about two days). 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 NCT03449277, which also lists 6 linked publications.
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 4 Apr 2018.