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OpenTrials
Completed

NCT Number: NCT01013558

New Options for Preoperative Anesthesia in Intrauterine Needling

The concept of fetal pain is becoming increasingly relevant due to growing possibilities for invasive intrauterine treatment. There is much debate as to whether the fetus is mature enough to be able to perceive pain at all. Recent studies have suggested that the fetus is at least capable of exhibiting a stress response to intrauterine needling. Intrauterine transfusions are most commonly performed by inserting a needle either in the umbilical cord root at the placental surface, or in the intrahepatic portion of the umbilical vein of the fetus. Recently, intrauterine needling in the intrahepatic vein has been shown to result in alterations in fetal stress hormones, which has been interpreted as a reaction to pain. These changes were not observed in intrauterine needling in the umbilical cord root, or after administration of analgesics to the fetus. The investigators tested the hypothesis that remifentanil provides fetal analgesia, assessed by a reduced fetal stress response. The investigators performed a randomised controlled trial comparing fetal stress response between patients undergoing intrauterine transfusions for alloimmune fetal anemia receiving remifentanil, or placebo.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • singleton pregnancy
  • clinically indicated intrauterine transfusion
  • red cell alloimmunisation

Exclusion criteria

  • severe adipositas
  • suspicion of structural anomalies
  • fetal hydrops
  • contraindication for remifentanil

Treatment and study plan

Remifentanil

Drug

0.15 microgram/kg/min continuous infusion.

Saline

Drug

continuous infusion

Primary outcomes

  1. evidence of fetal stress response by changes in fetal stress hormones beta-endorphin, noradrenalin and cortisol

    Time frame: 15-60 minutes

Secondary outcomes

  1. influence of analgesics (remifentanil) on the fetal stress response

    Time frame: 15-60 minutes

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • Leuven University Medical Center

Registry information

Official study title

NO PAIN: New Options for Preoperative Anesthesia in Intrauterine Needling

Acronym: NO PAIN

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Nov 13, 2009
Registry last updated
Dec 8, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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