Blood Pressure, Antihypertensive Treatment and Preeclampsia in Pregnant Wom-en With Pre-existing Diabetes

Pregnancy in Diabetics Clinical Trial

Official title:

Blood Pressure, Antihypertensive Treatment and Preeclampsia in Pregnant Wom-en With Pre-existing Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02890836
• Other study ID #: H-15019186
• Status: Completed
• Start date: February 2016
• Est. completion date: February 2021

Study information

• Verified date: May 2021
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Aim: First, to investigate the prevalence of a) confirmed hypertension, b) white coat hypertension and c) normal blood pressure in pregnant women with pre-existing diabetes. Second, to explore the prevalence of preeclampsia and preterm delivery in women with pre-existing diabetes with a) confirmed hypertension, b) white coat hypertension and c) normal blood pressure before entering the third trimester of pregnancy. Third, to explore the influence of lifestyle, gestational weight gain and mental well-being on confirmed hypertension and preeclampsia in pregnant women with diabetes.The recruitment period was in 2018 extended to 2020 to perform the following studies: First whether home BP in early pregnancy is superior to office BP to predict preeclampsia. Second to evaluate the prevalence of preeclampsia after initiation of a new treatment strategy including prophylactic aspirin and, in case of insufficiency, vitamin D supplementation.

Design: A prospective multicentre observational study where approximately 400 pregnant women with pre-existing diabetes are offered measurements of office blood pressure (BP) and home BP for three days three times during pregnancy as well as when the routinely measured office BP exceeds 135/85 mmHg. The prevalence of confirmed hypertension (office BP >135/85 mmHg and home BP >130/80 mmHg) and white coat hypertension (office BP >135/85 mmHg but home BP ≤130/80 mmHg) will be determined. Women with confirmed hypertension are offered antihypertensive treatment mainly with methyldopa. In women with a) confirmed hypertension, b) white coat hypertension, and c) normal blood pressure before entering third trimester of pregnancy, the prevalence of preeclampsia and preterm delivery will be evaluated. Possible side effects of antihypertensive treatment including impaired fetal haemodynamics and lower infant birth weight will be recorded. The women will complete food diaries and questionnaires on lifestyle and mental health three times in pregnancy in order to evaluate the influence of these parameters on hypertension and preeclampsia.

Description:

Design: Home blood pressure and office blood pressure as predictors of preeclampsia will be evaluated in the total cohort. From February 2018, the routine care includes treatment with prophylactic aspirin in all women with pre-existing diabetes and screening for vitamin D insufficiency, treated with vitamin D depending on the severity of the insufficiency. The prevalence of preeclampsia after initiation of the new treatment strategy will be evaluated. The women included from 2016-2018, where aspirin was only initiated if other risk factors to preeclampsia apart from diabetes were present, will be used for comparison.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 513
• Est. completion date: February 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Inclusion criteria for pregnant women with diabetes:

• Women with pre-existing diabetes, older than 18 years and referred to The Center for Pregnant Women with Diabetes, Rigshospitalet, or the Centre for Diabetes and Pregnancy, Odense University Hospital, with a live singleton or twin pregnancy before 20 weeks during the inclusion period.

• Women with diabetes diagnosed in pregnancy before 20 weeks (HbA1c =48 mmol/mol) may also be included as having type 2 diabetes.

• Sufficient Danish language skills to read and understand the patient information sheet and to converse.

Inclusion criteria for pregnant healthy women without diabetes:

• Women above 18 years of age, with a live singleton pregnancy, referred to a nuchal translucency scan at 11-14 weeks at The Department of Obstetrics, Rigshospitalet.

• Sufficient Danish language skills to read and understand the patient information sheet and to converse.

Exclusion Criteria:

Exclusion criteria for both study groups:

• Women diagnosed with severe diseases that could possibly bias BP measurements or pregnancy outcome. This is judged by the principal investigators.

Related Conditions & MeSH terms

• Pre-Eclampsia
• Pregnancy in Diabetics

Intervention

Drug:
• Antihypertensiva, mainly Metyldopa

Locations

Country	Name	City	State
Denmark	Center for Pregnant Women with Diabetes	Copenhagen	Kbh Ø

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Infant birth weight SD-score		4 years
Other	Large for gestational age		4 years
Other	Small for gestational age		4 years
Other	Ponderal index		2 years
Other	Gestational weight gain		4 years
Other	Caesarean section		4 years
Other	Shoulder dystocia		4 years
Other	Degree of rupture		2 years
Other	Duration from induction of labour to delivery		2 years
Other	Duration of active labour		2 years
Other	Major congenital malformations	Malformations that include ICD 10 codes: Q00-Q99. In addition, a congenital abnormality that requires medical or surgical treatment, has a serious adverse effect on health and development, or has significant cosmetic impact	4 years
Other	Perinatal mortality	Perinatal death includes infant deaths that occur at less than 28 days of age and fetal deaths with a stated or presumed period of gestation of 20 weeks or more	4 years
Other	Perinatal morbidity	The occurrence of at least one of the following complications: neonatal hypoglycaemia, neonatal jaundice, transient tachypnea of the newborn or admission to neonatal intensive care unit within the first 28 days of life	4 years
Other	Neonatal hypoglycaemia (Danish definition)	Plasma glucose <5 mmol/L, measured within 4 hours of life.	4 years
Other	Neonatal hypoglycaemia (common international)	Neonatal hypoglycemia defined as a plasma glucose value < 2.2 mmol/L, measured within 4 hours of life	4 years
Other	Jaundice		4 years
Other	Transient tachypnea of the newborn	A need for Continuous Positive Airway Pressure for more than 60 minutes	4 years
Other	Apgar score	A measure of the health of a newborn infant done at 1 and 5 min. The newborn is given points (0, 1, 2) for heart rate, respiratory effort, muscle tone, response to stimulation and skin coloration. A score of 10 points indicates excellent health.	4 years
Other	Microalbuminuria	30-300 mg/day albumin or ACR, 30-300 mg/g of creatinine or 3.4-34 mg/mmol of creatinine	4 years
Other	Diabetic nephropathy	U-albumin >300 mg/day or albumin to creatinine ratio>300 mg/g of creatinine or >34 mg/mmol of creatinine	4 years
Other	Diabetic retinopathy	Presence of any diabetic retinopathy at first examination in pregnancy	4 years
Other	Kidney involvement	Diabetic nephropathy or microalbuminuria	4 years
Other	Pulsatility index (PI) of the middle cerebral artery (MCA) measured with Doppler flow measurements		2 years
Other	Pulsatility index (PI) of the umbilical artery (UA) measured with Doppler flow		2 years
Other	Ratio of the pulsatility index (PI) of the middle cerebral artery and the umbilical artery		2 years
Other	Body mass index (BMI)		4 years
Primary	Confirmed hypertension	Office blood pressure >135/85 mmHg measured twice at least 4 hours apart and home blood pressure >130/80 mmHg in pregnancy, or diagnosed hypertension with antihypertensive treatment from before pregnancy	2 years
Primary	White coat hypertension	Office blood pressure >135/85 mmHg measured twice at least 4 hours apart, but home blood pressure =130/80 mmHg	2 years
Primary	Preeclampsia		4 years
Primary	Early preeclampsia	Preeclampsia occurring before 34 weeks	4 years
Primary	Preterm birth	Birth before 37 completed weeks	4 years
Primary	Early preterm delivery (international)	Birth before 32 completed weeks	4 years
Primary	Early preterm delivery (Danish)	Birth before 34 completed weeks	4 years
Secondary	Gestational hypertension	De novo hypertension appearing after 20 weeks	4 years
Secondary	Chronic hypertension	Hypertension diagnosed prior to pregnancy, or during pregnancy before 20 weeks	4 years