Asthma during pregnancy

Asthma during pregnancy, an observational prospective cohort study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN15914889

Enrollment

250

Registered

2023-11-30

Start date

2018-09-01

Completion date

Unknown

Last updated

2023-12-12

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

Conditions

Asthma, pregnancy Pregnancy and Childbirth

Interventions

This is a single-centre, non-interventional, prospective observation cohort study. First consultation: lung function, questionnaires and laboratory testing. Patients st

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: All pregnant women (>18 years) with a doctor's diagnosis of asthma referred to the asthma pregnancy outpatient clinic of the HAGA teaching Hospital.

Exclusion criteria

Exclusion criteria: 1. Non pregnant 2. Not referred to secondary care

Design outcomes

Primary

Measure	Time frame
1. 6 item ACQ (asthma control questionnaire questionnaire) at visit 1 (baseline) and 2 2. 32 item AQLQ (asthma quality of life questionnaire) at visit 1 3. 6 item HCU (health care utilization questionnaire) at visit 1 4. 5 item pregnancy asthma control test 5. Lung function measurements; FEV1, FVC and FEV1/FVC measures by Spirometry at baseline, and visit 2 only when indicated by the attending healthcare provider (respiratory physician) FeNO measurement at visit 1 and visit 2 6. Asthma exacerbations during pregnancy (by reviewing the electronic patient file and dispensing data from patients and hospital pharmacy) (Severe asthma exacerbations were defined by at least one of the following criteria: 6.1. Patient reported use of OCS courses (if not on maintenance OCS) 6.2. Patient reported doubling of maintenance dose of OCS for at least 3 days 6.3. Patient reported unscheduled emergency visits or hospitalization for asthma exacerbation), poorly controlled maternal asthma during pregnancy (measured by ACQ and the pregnancy asthma control test) 7. Adverse pregnancy outcomes (maternal and perinatal outcomes); pre-eclampsia, pregnancy induced hypertension, low birth weight, pre term delivery, small for gestational age, perinatal mortality, admission on neonatal ICU, congenital malformations. Maternal and fetal outcomes and delivery parameters are collected from the medical records after delivery. For those patients who are no longer in our care, information is requested from their treating general practitioner or midwife.	—

Measure

Time frame

1. 6 item ACQ (asthma control questionnaire questionnaire) at visit 1 (baseline) and 2 2. 32 item AQLQ (asthma quality of life questionnaire) at visit 1 3. 6 item HCU (health care utilization questionnaire) at visit 1 4. 5 item pregnancy asthma control test 5. Lung function measurements; FEV1, FVC and FEV1/FVC measures by Spirometry at baseline, and visit 2 only when indicated by the attending healthcare provider (respiratory physician) FeNO measurement at visit 1 and visit 2 6. Asthma exacerbations during pregnancy (by reviewing the electronic patient file and dispensing data from patients and hospital pharmacy) (Severe asthma exacerbations were defined by at least one of the following criteria: 6.1. Patient reported use of OCS courses (if not on maintenance OCS) 6.2. Patient reported doubling of maintenance dose of OCS for at least 3 days 6.3. Patient reported unscheduled emergency visits or hospitalization for asthma exacerbation), poorly controlled maternal asthma during pregnancy (measured by ACQ and the pregnancy asthma control test) 7. Adverse pregnancy outcomes (maternal and perinatal outcomes); pre-eclampsia, pregnancy induced hypertension, low birth weight, pre term delivery, small for gestational age, perinatal mortality, admission on neonatal ICU, congenital malformations. Maternal and fetal outcomes and delivery parameters are collected from the medical records after delivery. For those patients who are no longer in our care, information is requested from their treating general practitioner or midwife.

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

Netherlands

Contacts

Public ContactSarah Bendien

s.vannederveen@hagaziekenhuis.nl+31 639592319

Outcome results

None listed

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