Complications during pregnancy
Conditions
Interventions
None listed
Sponsors
Maxima Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Pregnant women, carrying a healthy, singleton fetus with a gestational age between 20 and 42 weeks, receiving one or more of the following medicines; tocolytic drugs, corticosteroids, antihypertensive agents or medication for sedation or pain relief during labour. Patients receiving both tocolytic drugs and corticosteroids at the same time can participate in this study, since this is standard care nowadays. Also patients receiving antihypertensive agents and corticosteroids simultaneously can be included in this study. In this way, we will get information that is applicable in daily clinical practice.
Exclusion criteria
Exclusion criteria: Women under the age of 18 years old, using other medicines than examined in this study, multiple pregnancies, women carrying a fetus with a known congenital malformation and fetuses with an intra-uterine growth restriction are excluded (defined as a fetal growth lower than p5 as estimated by echography). Fetal congenital malformations discovered after inclusion will be analysed separately.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurements are performed using ten self-adhesive electrodes, placed in a fixed configuration on the maternal abdomen. A non-invasive electrophysiologic monitor for obstetrics (NEMO), is used to record and store the electrical activity on the maternal abdomen. The collected data will be analysed off-line. The maternal electrocardiogram (ECG) is removed, without affecting the present fECG-complexes. Sympathetic and parasympathetic activity are determined by calculating the power in the low frequency (LF; 0.04-0.15 Hz) and high frequency (HF; 0.4-1.5 Hz) spectral band, respectively. This energy can be expressed in absolute units (LF and HF) or normalised units (LFn and HFn); for more information; see protocol page 9. We will conduct a baseline measurement (*0-measurement*), before administration of the medicine or, when this is not feasible, after the effects of the medicine is vanished. This will be determined by the half-life of the specific medicine (for more information, see protocol chapter 3, page 11). Measurements will be repeated at established time intervals, depending on the pharmacokinetics of the specific medicine. The primary study parameters are the differences in LF, LFn, HF, HFn and LF/HF-ratio, that manifest in the measurements before and after administration of the medicine. The expected changes are different for every used medicine, and because of the lack of prior studies it is hard to predict these changes. Because the measurements take 30-45 minutes, it is unlikely that these differences are solely caused by fetal behavioural stages, fetal body movements or compression of the umbilical cord. | — |
Secondary
| Measure | Time frame |
|---|---|
| As secondary analysis, we will conduct measurements of the maternal electrohysterogram. This will be extracted from a electrode patch, placed on the maternal abdomen. We will analyse the effect of the medication on the uterine activity. Postpartum, general information regarding the delivery will be obtained from the obstetric caregiver at the time of delivery. This will be noted on a separate *follow-up postpartum* file and constitutes the inclusion number of the patient, date of birth of the child, gestational age at birth, birth weight, sex, Apgar score (1, 5 and 10 minute score), postpartum events and cardiac problems postpartum. | — |
Countries
Netherlands
Outcome results
None listed