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Cervical Rippening With Antiprogesterone in Midtrimester Abortions

H

Hadassah Medical Center

Status and phase

Completed
Phase 4

Conditions

Abortion, Missed

Treatments

Drug: Mifepristone

Study type

Interventional

Funder types

Other

Identifiers

NCT00410345
mifepristoneoxytocin-HMO-CTIL

Details and patient eligibility

About

Induction of midtrimester abortion includes cervical ripening and then contraction to induce uterine evacuation. There are several protocols, but most of them include using prostaglandins (PG). The disadvantages of using PG include uncomfortable side effects and limits of using it for women after cesarean section. Mifepristone is an antiprogesterone drug and been used for induction of abortion in first and second trimesters abortions. The aim of this study is to explore the effectiveness of Mifepristone for cervical ripening before high dose Oxytocin drip.

Full description

The aim of this study is to explore the effectiveness of Mifepristone for cervical ripening before high dose Oxytocin drip in midtrimester abortions. After informed consent, all the women will be randomized for Mifepristone or placebo. 48 hours later, high dose oxytocin drip will be started and we will examine the success rate to induce abortion, the duration from starting oxytocin till evacuation of uterus and side effects.

Enrollment

145 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • midtrimester late abortion
  • midtrimester induced abortion

Exclusion criteria

  • placenta previa
  • infected abortion
  • rupture of membranes
  • s/p cesarean section *2 or more

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

145 participants in 2 patient groups

Pitocin
Experimental group
Description:
Treatment with Pitocin after mifegine
Treatment:
Drug: Mifepristone
Cytotec
Active Comparator group
Description:
Treatment with cytotec after mifegine
Treatment:
Drug: Mifepristone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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