Severe Pre-Eclampsia, AntepartumPhase 2/3NCT03325348
Oral Nifedipine Versus IV Labetalol in Severe Pre Eclampsia
A Phase 2/3 study testing Nifedipine 10 mg and Labetalol in people with Severe Pre-Eclampsia, Antepartum, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
Trial summary
OBJECTIVE: To determine the efficacy of nifedipine and labetalol in terms of control of BP in pre eclamptic pregnant patients Design: Randomised control trial SETTING: Department Obstetrics \& gynaecology, Services Hospital, Services Institute of Medical Sciences. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Severe Pre-Eclampsia, Antepartum
- What is being tested?
- Nifedipine 10 mg and Labetalol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 sitePakistan
- Study dates
- 23 Feb 2017to 15 Jan 2018
- Phase
- Phase 2/3
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gestational age 24 to 41 weeks
- BP > 160/110 mm Hg with proteinuria
- Patients with S/S of imminent eclampsia as headache, visual disturbance.
Who cannot join
- Gestational age < 24 wks
- Non proteinuric chronic hypertension
- Eclampsia
- Cardiac patients, asthma, severe renal disease, allergy to Nifedipine or Labetalol
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Services Institute of Medical Sciences
Lahore, Punjab Province
TAYYIBA WASIM, FCPS, +923008400197, tayyibawasim@yahoo.com
Natasha Usman, FCPS, natashausman5@hotmail.com
About this study
Official title: Oral Nifedipine Versus IV Labetalol in Treatment of Severe Pre Eclampsia in Pregnancy
OBJECTIVE: To determine the efficacy of nifedipine and labetalol in terms of control of BP in pre eclamptic pregnant patients
Design: Randomised control trial
Read more
SETTING: Department Obstetrics \& gynaecology, Services Hospital, Services Institute of Medical Sciences. Lahore
POPULATION: Pregnant patients with BP 160/110 or symptoms of severe preeclampsia
METHODS: Patients are randomised to receive nifedipine (10 mg tablet, orally, up to five doses) and intravenous placebo saline injection or intravenous labetalol injection (in an escalating dose regimen of 20, 40, 80, 80 and 80 mg) and a placebo tablet every 15 minutes until the target blood pressure of ≤140/90mmHg is achieved. Crossover treatment is given if the initial treatment regimen is unsuccessful
Read the detailed description
Gestational hypertension is associated with increased risk of maternal morbidity and mortality. Parenteral therapy needs more resources, more monitoring and supervision. Oral therapy is cheap, easily available, easy to administer especially in resource constrained settings
OBJECTIVE: To determine the efficacy of nifedipine and labetalol in terms of control of BP in pre eclamptic pregnant patients
Design: Randomised control trial SETTING: Department Obstetrics \& gynaecology, Services Hospital, Services Institute of Medical Sciences.Lahore POPULATION: Pregnant patients with BP 160/110 mm Hg or symptoms of severe preeclampsia
METHODS: Patients are randomised to receive nifedipine (10 mg tablet, orally, up to five doses) and intravenous placebo saline injection or intravenous labetalol injection (in an escalating dose regimen of 20, 40, 80, 80 and 80 mg) and a placebo tablet every 15 minutes until the target blood pressure of ≤140/90mmHg is achieved. Crossover treatment is given if the initial treatment regimen is unsuccessful
- Conditions
- Severe Pre-Eclampsia, Antepartum
- Being tested
- Nifedipine 10 mg, Labetalol
- Keywords
- Severe Pre eclampsia, Nifidepine, Labetalol
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifedipine 10 mgDrug
Also called Cap nefidil 10 mg
Nifedipine 10mg oral tablet with 1 ml 0.9% n/saline will be given to patients every 15 min uptil one hour
LabetalolDrug
Also called Labetalol Hydrochloride injection
IV labetalol 20 mg \& mint tablet will be given to patients every 15 min until one hour
| Study group | Role | What they receive |
|---|---|---|
| Oral Nifedipine | Experimental | Nifedipine 10mg oral tablet \& 1ml 0.9%N/Saline will be given every 15 minutes up till one hour Receives: Drug: Nifedipine 10 mg |
| IV Labetalol | Active comparator | IV labetalol 20 mg and mint tablet will be given every 15 minutes up till one hour Receives: Drug: Labetalol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time taken for Blood Pressure control
Time taken to control Blood pressure will be measured
Measured: 60 minutes
Secondary outcomes (3)
Fetal distress
Fetal distress will be measured by abnormalities of fetal heart rate of fetus or passage of meconium.
of Meconium
Measured: Labour
Neonatal Intensive Care Unit admission,
If neonate needs Neonatal Intensive Care Unit admission for more than 12 hours
Measured: From Birth till 7 days
perinatal death
If death of baby occurs in utero or within 7 days of delivery
Measured: From birth to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start23 Feb 2017
- Primary completionDec 2017 (estimated)
- Study completion15 Jan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Pre-Eclampsia, AntepartumStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Services Institute of Medical Sciences, Pakistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tayyiba Wasim, Services Institute of Medical Sciences, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325348
- Sponsor's protocol ID
- IRB/2017/306/SIMS
- Status last verified
- Oct 2017
- First submitted
- 30 Sep 2017
- Last updated
- 30 Oct 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 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Nifedipine Versus IV Labetalol in Treatment of Severe Pre Eclampsia in Pregnancy
- ClinicalTrials.gov ID
- NCT03325348
- Acronym / sponsor ID
- IRB/2017/306/SIMS
- Conditions
- Severe Pre-Eclampsia, Antepartum
- Keywords
- Severe Pre eclampsia, Nifidepine, Labetalol
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Services Institute of Medical Sciences, PakistanOther government
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- 15 Jan 2018 (estimated)
- First posted
- 30 Oct 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.
OBJECTIVE: To determine the efficacy of nifedipine and labetalol in terms of control of BP in pre eclamptic pregnant patients
Design: Randomised control trial
SETTING: Department Obstetrics \& gynaecology, Services Hospital, Services Institute of Medical Sciences. Lahore
POPULATION: Pregnant patients with BP 160/110 or symptoms of severe preeclampsia
METHODS: Patients are randomised to receive nifedipine (10 mg tablet, orally, up to five doses) and intravenous placebo saline injection or intravenous labetalol injection (in an escalating dose regimen of 20, 40, 80, 80 and 80 mg) and a placebo tablet every 15 minutes until the target blood pressure of ≤140/90mmHg is achieved. Crossover treatment is given if the initial treatment regimen is unsuccessful
Detailed description
Gestational hypertension is associated with increased risk of maternal morbidity and mortality. Parenteral therapy needs more resources, more monitoring and supervision. Oral therapy is cheap, easily available, easy to administer especially in resource constrained settings
OBJECTIVE: To determine the efficacy of nifedipine and labetalol in terms of control of BP in pre eclamptic pregnant patients
Design: Randomised control trial SETTING: Department Obstetrics \& gynaecology, Services Hospital, Services Institute of Medical Sciences.Lahore POPULATION: Pregnant patients with BP 160/110 mm Hg or symptoms of severe preeclampsia
METHODS: Patients are randomised to receive nifedipine (10 mg tablet, orally, up to five doses) and intravenous placebo saline injection or intravenous labetalol injection (in an escalating dose regimen of 20, 40, 80, 80 and 80 mg) and a placebo tablet every 15 minutes until the target blood pressure of ≤140/90mmHg is achieved. Crossover treatment is given if the initial treatment regimen is unsuccessful
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Nifedipine | Experimental | Drug: Nifedipine 10 mgNifedipine 10mg oral tablet \& 1ml 0.9%N/Saline will be given every 15 minutes up till one hour |
| IV Labetalol | Active comparator | Drug: LabetalolIV labetalol 20 mg and mint tablet will be given every 15 minutes up till one hour |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Gestational age 24 to 41 weeks
- BP > 160/110 mm Hg with proteinuria
- Patients with S/S of imminent eclampsia as headache, visual disturbance.
Key exclusion criteria (4 listed)
- Gestational age < 24 wks
- Non proteinuric chronic hypertension
- Eclampsia
- Cardiac patients, asthma, severe renal disease, allergy 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 |
|---|---|---|
| Nifedipine 10 mgAlso: Cap nefidil 10 mgNifedipine 10mg oral tablet with 1 ml 0.9% n/saline will be given to patients every 15 min uptil one hour | Drug | Oral Nifedipine |
| LabetalolAlso: Labetalol Hydrochloride injectionIV labetalol 20 mg \& mint tablet will be given to patients every 15 min until one hour | Drug | IV Labetalol |
Primary outcome
Time taken for Blood Pressure control
Time frame: 60 minutes
Time taken to control Blood pressure will be measured
3 secondary outcomes
Fetal distress
Time frame: Labour
Neonatal Intensive Care Unit admission,
Time frame: From Birth till 7 days
perinatal death
Time frame: From birth to 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nifedipine 10 mg and Labetalol in people with Severe Pre-Eclampsia, Antepartum, run by Services Institute of Medical Sciences, Pakistan 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 3 inclusion and 4 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 30 Oct 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 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Tayyiba Wasim, FCPS (+923008400197, tayyibawasim@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time taken for Blood Pressure control (time frame: 60 minutes). 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 30 Oct 2017.