The applicability of measuring skin-conductance in pre-eclamptic and non-pre-eclamptic pregnant patients.

Withdrawn

Conditions: Pre-eclampsia
toxemia of pregnancy
10026908

Registration Number: NL-OMON35258

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

PART A
For this part, we will invite patients to participate, who are already enrolled in the MUPPIT study (Markers of UncomPlicated Pregnancies In 1st Trimester. Protocol 07-222). The MUPPIT study investigates maternal serum markers in the first half of pregnancy in patients that are at risk of developing preeclampsia, to develop a prediction rule for preeclampsia in their current pregnancy. Patients are enrolled at six-seven weeks of pregnancy. Every two weeks blood samples will be taken and bloodpressure will be measured. At twelve weeks of gestational age measurement of the Doppler wave form of the uterine artery takes place. Women will be included in this study after pregnancy conceived by IVF, when they have diabetes type I or type II or when they had severe preeclampsia or fetal growth restriction in their preceding pregnancies. Twin pregnancies and women pregnant of a fetus with chromosomal abnormalities will be excluded.;Participation in the present study only requires approximately 1 hour extra time investment in addition to the MUPPIT-study, mostly spend in relaxely lying on their back on a bed. As we do not subject the participants to any invasive procedures, we feel that the extra time involves minimal extra burden or risk to the participants. These participants already travelled to the hospital because of their participation in the MUPPIT study (no extra travelling time).;Inclusion study
Only women who are pregnant with severe preeclampsia or fetal growth restriction in previous pregnancies will be invited to participate (primi- and multiparous). Recruitment and inclusion takes place at the outpatient clinic when patients have their MUPPIT appointment at 6, 8 or 10 weeks of pregnancy. Measurement takes place at 12 weeks of pregnancy after completion of the Doppler measurement on behalf of the MUPPIT study.;Control group: Healthy pregnant women, subjected to an ultrasound measurement at twelve weeks of pregnancy. Recruitment takes place by telephone, two weeks before patients have their appointment at the outpatient clinic. Measurement takes place immediately after the ultrasound appointment. Patients will be matched for maternal and gestational age.;PART B
Our population consists of (primi- and multiparous) preeclamptic patients or patients suspected of having preeclampsia. Recruitment takes place at the obstetrical ward of the University Medical Centre Utrecht (UMC Utrecht). Patients are diagnosed with preeclampsia when their arterial blood pressure is * 140/90 mmHg (on at least two separate occasions) accompanied by proteinuria in excess of *300mg/24 hour. They have been normotensive before. They require magnesium sulphate treatment because of increased risk to develop eclampsia. Age can be expected to range from 25 to 40 years. Gestational age varies from 26-40 weeks.;Control group: Recruitment takes place among pregnant patients that are admited at the obstetrical ward because of a pregnancy complication not associated with a hypertensive disorder.

Exclusion Criteria

PART A
Patients will be excluded if they have secondary hypertension or chronic diseases that can influence the autonomic nervous system, such as diabetes mellitus, malignancy or neurological disorders. Twin pregnancies and women pregnant of a fetus with chromosomal abnormalities will be excluded as well.;Control group: Patients will be excluded when they have secondary hypertension or chronic diseases potentially affecting the autonomic nervous system, such as diabetes mellitus, malignancy or a neurological disorder. Twin pregnancies and women pregnant of a fetus with chromosomal abnormalities will also been excluded.;PART B
Patients will be excluded if they have secondary hypertension or chronic diseases that can influence the autonomic nervous system, such as diabetes mellitus, malignancy or neurological disorders. Twin pregnancies and women pregnant of a fetus with chromosomal abnormalities will be excluded as well. Furthermore, patients with severe preeclampsia, who need immediately magnesium sulphate prophylaxis (since patients have 24 hours to consider their participation, and measuring will postpone prophylaxis) , will not be included in the study.
Control group: Patients will be excluded if they have secondary hypertension or chronic diseases that can influence the autonomic nervous system, such as diabetes mellitus, malignancy or neurological disorders. Twin pregnancies and women pregnant of a fetus with chromosomal abnormalities will be excluded as well.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome variables will be the mean PEP and SCL. The endpoint is<br /><br>preeclampsia.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameters in PART A consist of the mean PEP and mean SCL<br /><br>after the tilt-test in healthy pregnant women and pregnant women at risk of<br /><br>developing preeclampsia.<br /><br><br /><br>The secondary study parameters in PART B consists of the mean PEP and mean SCL<br /><br>after the tilt-test in non-pre-elcamptic pregnant women and preeclamptic women<br /><br>when admitted to the obstetrical ward and the mean differences in PEP and SCL<br /><br>during and after magnesium sulphate treatment in preeclamptic patients.<br /><br><br /><br>The secondary study parameters will further be the bloodpressure, the ECG and<br /><br>the ICG, and the information received out of diaries patients are writing<br /><br>during treatment with magnesium sulphate.</p><br>