Status:

COMPLETED

The Copenhagen Analgesic Study

Lead Sponsor:

Rigshospitalet, Denmark

Conditions:

Gonad Regulating Hormone Adverse Reaction

Analgesic Adverse Reaction

Eligibility:

All Genders

18+ years

Brief Summary

Fundamental aspects of reproductive function are established in fetal life and there is a present increased awareness of the potential effects of fetal exposures on reproductive health of offspring. E...

Detailed Description

Fetal gonadal development is essential for adult reproductive health. Experimental studies strongly suggest that maternal use of mild analgesics (e.g. paracetamol and non-steroidal anti-inflammatory d...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Infants:
  • Singleton pregnancies
  • Term pregnancy (week 37+0 to 42+0)
  • Parents:
  • Maternal and paternal Caucasian origin
  • Maternal pre-pregnancy BMI between 18 and 35 kg/m2
  • Exclusion criteria:
  • Infants:
  • • Fetal malformations or chromosomal disorders
  • Parents:
  • Serious maternal illness, including pre-existing maternal diabetes or thyroid gland diseases
  • Gestational diabetes

Exclusion

    Key Trial Info

    Start Date :

    March 1 2020

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    November 30 2022

    Estimated Enrollment :

    685 Patients enrolled

    Trial Details

    Trial ID

    NCT04369222

    Start Date

    March 1 2020

    End Date

    November 30 2022

    Last Update

    July 10 2025

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Department of Growth and Reproduction, Rigshospitalet

    Copenhagen, Denmark, 2100

    2

    Department of Obstetrics and Section of fetal medicine, Rigshospitalet

    Copenhagen, Denmark, 2100