Pregnancy And chronic hypertension: NifeDipine or labetalol as Antihypertensive treatment

Pregnancy And chronic hypertension: NifeDipine or labetalol as Antihypertensive treatment - PANDA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003144-23-GB

Enrollment

Unknown

Registered

2013-10-30

Start date

2014-02-03

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hypertension in pregnancy MedDRA version: 16.1 Level: LLT Classification code 10036695 Term: Primary hypertension System Organ Class: 10047065 - Vascular disorders MedDRA version: 16.1 Level: PT Classification code 10039834 Term: Secondary hypertension System Organ Class: 10047065 - Vascular disorders MedDRA version: 16.1 Level: PT Classification code 10015488 Term: Essential hypertension System Organ Class: 10047065 - Vascular disorders

Interventions

Trade Name: NIFEDIPRESS MR 20 and NIFEDIPRESS MR 10 Pharmaceutical Form: Tablet INN or Proposed INN: NIFEDIPINE CAS Number: 21829-25-4 Concentration unit: mg milligram(s) Concentration type: range Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Chronic hypertension (defined as diastolic blood pressure (BP) >=90mmHg present at booking or before 20 weeks' gestation, or requiring treatment outside pregnancy and/or at time of referral) •Gestation 12-28 weeks’ gestation •Singleton pregnancy •Able to provide informed consent •Age >=18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 114 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: •Contraindication to labetalol (including asthma, uncontrolled heart failure, Prinzmetal's angina, marked bradycardia, hypotension, sick sinus syndrome, second- or third- degree AV block, cardiogenic shock, metabolic acidosis, severe peripheral arterial disease; phaeochromocytoma) or nifedipine (including cardiogenic shock; advanced aortic stenosis; within 1 month of myocardial infarction; unstable or acute attacks of angina) •Insufficient understanding of the trial

Design outcomes

Primary

Measure	Time frame
Main Objective: To undertake a feasibility study for a randomised controlled trial comparing labetalol and nifedipine in pregnant women with chronic hypertension, with planned assessment of ethnic variation in drug response ;Secondary Objective: •To evaluate maternal and perinatal outcomes •To determine health resource use •To assess whether differential response to antihypertensive treatments is explained by biomarkers and/or vascular function parameters ;Primary end point(s): Primary Process Endpoint: •Number recruited per site per month Primary Clinical Endpoint: •Highest systolic BP post-randomisation ;Timepoint(s) of evaluation of this end point: Women will take part in the trial for a maximum of 30 weeks of their pregnancy. We plan to recruit 114 women and anticipate the last woman will be recruited one year after commencing the study, so the study would end 30 weeks after this time. Evaluation of both primary outcomes would be possible at this point.	—

Measure

Time frame

Main Objective: To undertake a feasibility study for a randomised controlled trial comparing labetalol and nifedipine in pregnant women with chronic hypertension, with planned assessment of ethnic variation in drug response ;Secondary Objective: •To evaluate maternal and perinatal outcomes •To determine health resource use •To assess whether differential response to antihypertensive treatments is explained by biomarkers and/or vascular function parameters ;Primary end point(s): Primary Process Endpoint: •Number recruited per site per month Primary Clinical Endpoint: •Highest systolic BP post-randomisation ;Timepoint(s) of evaluation of this end point: Women will take part in the trial for a maximum of 30 weeks of their pregnancy. We plan to recruit 114 women and anticipate the last woman will be recruited one year after commencing the study, so the study would end 30 weeks after this time. Evaluation of both primary outcomes would be possible at this point.

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Most of the secondary outcomes will be evaluated immediately once the last recruit has been followed up at 6 weeks post delivery of the last participant, but the explanatory biomarker studies may take up to 3 years to complete.;Secondary end point(s): Clinical: •Maternal outcomes including: -maternal morbidity or mortality (pre-eclampsia, eclampsia, intracranial haemorrhage or infarct, myocardial ischaemia/infarction, intubation, pulmonary oedema, hepatic dysfunction, acute renal insufficiency, placental abruption, post-partum haemorrhage) - gestation at delivery - mode of delivery - indication for delivery - number of episodes of systolic BP >=160mmHg, >=150mmHg (including home monitoring) - diastolic BP <80mmHg - need for additional oral or parenteral antihypertensives •Perinatal outcomes including: -neonatal morbidity (admission to neonatal unit (length and place of stay), respiratory distress syndrome, need for ventilator support, intraventricular haemorrhage, confirmed infection, necrotising enterocolitis, seizures, encephalopathy, retinopathy of prematurity, other indications and main diagnoses related to neonatal unit admission) - abnormal umbilical artery Doppler waveforms, - stillbirth - neonatal death - birth weight - birth weight centile - umbilical artery pH at birth •Health resource use outcomes including: - number of antenatal attendances (clinic and day unit) - maternal admission nights (ward, delivery suite, intensive care) - neonatal admission nights (including level of care) •Explanatory biomarker and vascular function assessments Process: •Medication adherence (through self-report and pill count) •Side-effects of medication •Satisfaction with medication (assessed through postnatal questionnaire)	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Most of the secondary outcomes will be evaluated immediately once the last recruit has been followed up at 6 weeks post delivery of the last participant, but the explanatory biomarker studies may take up to 3 years to complete.;Secondary end point(s): Clinical: •Maternal outcomes including: -maternal morbidity or mortality (pre-eclampsia, eclampsia, intracranial haemorrhage or infarct, myocardial ischaemia/infarction, intubation, pulmonary oedema, hepatic dysfunction, acute renal insufficiency, placental abruption, post-partum haemorrhage) - gestation at delivery - mode of delivery - indication for delivery - number of episodes of systolic BP >=160mmHg, >=150mmHg (including home monitoring) - diastolic BP <80mmHg - need for additional oral or parenteral antihypertensives •Perinatal outcomes including: -neonatal morbidity (admission to neonatal unit (length and place of stay), respiratory distress syndrome, need for ventilator support, intraventricular haemorrhage, confirmed infection, necrotising enterocolitis, seizures, encephalopathy, retinopathy of prematurity, other indications and main diagnoses related to neonatal unit admission) - abnormal umbilical artery Doppler waveforms, - stillbirth - neonatal death - birth weight - birth weight centile - umbilical artery pH at birth •Health resource use outcomes including: - number of antenatal attendances (clinic and day unit) - maternal admission nights (ward, delivery suite, intensive care) - neonatal admission nights (including level of care) •Explanatory biomarker and vascular function assessments Process: •Medication adherence (through self-report and pill count) •Side-effects of medication •Satisfaction with medication (assessed through postnatal questionnaire)

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Countries

United Kingdom

Contacts

Public ContactLucy Chappell

King's Colllege London

lucy.chappell@kcl.ac.uk440207188 3639

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026