Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Medical Management of Late Intrauterine Death. (INPer)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02488642
Recruitment Status : Completed
First Posted : July 2, 2015
Last Update Posted : July 24, 2015
Sponsor:
Collaborator:
National Council of Science and Technology, Mexico
Information provided by (Responsible Party):
Gabriel Arteaga Troncoso, National Institute of Perinatology

Brief Summary:
The purpose of this study is to assess the therapeutic efficacy and safety of isosorbide dinitrate-oxytocin in combination in the management of late intrauterine foetal death.

Condition or disease Intervention/treatment Phase
Cervical Pregnancy Maternal Care for Late Fetal Death Drug: Isosorbide Dinitrate Drug: Misoprostol Drug: Oxytocin Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Medical Management of Late Intrauterine Death Using a Therapeutic Combination of Isosorbide Dinitrate and Oxytocin.
Study Start Date : May 2008
Actual Primary Completion Date : September 2013
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stillbirth

Arm Intervention/treatment
Experimental: isosorbide dinitrate-oxytocin

Preinduction with isosorbide dinitrate gel solution (80 mg/1.5 mL) were administered in the posterior fornix every 3 hours. Once a Bishop score of over 7 was reached, oxytocin was infused in a balanced electrolyte solution beginning with an infusion rate of 2 milli-International Units per minute (mIU/min) and doubling the dose every 15 minutes.

If the cervical conditions (<7 Bishop Score) did not change after the treatment application, a new dose, without exceeding 4 doses, to facilitate cervical ripening.

Drug: Isosorbide Dinitrate
Other Names:
  • Isordil
  • Dilatrate-SR
  • Sorbitrate

Drug: Oxytocin
Oxytocin was infused in a balanced electrolyte solution beginning with an infusion rate of 2 milli-International Units per minute (mIU/min) and doubling the dose every 15 minutes.

Placebo Comparator: misoprostol-oxytocin

Preinduction with misoprostol gel solution (100 mcg/1.5 mL) were administered in the posterior fornix every 3 hours. Once a Bishop score of over 7 was reached, oxytocin was infused in a balanced electrolyte solution beginning with an infusion rate of 2 milli-International Units per minute (mIU/min) and doubling the dose every 15 minutes.

If the cervical conditions (<7 Bishop score) did not change after the treatment application, participants received a new dose, without exceeding 4 doses, to facilitate cervical ripening.

Drug: Misoprostol
Other Name: Cytotec

Drug: Oxytocin
Oxytocin was infused in a balanced electrolyte solution beginning with an infusion rate of 2 milli-International Units per minute (mIU/min) and doubling the dose every 15 minutes.




Primary Outcome Measures :
  1. Rates of uterine expulsion in the women who received the isosorbide dinitrate-oxytocin regimen [ Time Frame: within 15 hours of administration ]

Secondary Outcome Measures :
  1. A Bishop score of >7 of administration of the first dose of isosorbide dinitrate [ Time Frame: within 12 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Closed cervix without evidence of cervical dilation or baseline uterine activity.
  • A Bishop score of <5, having intact membranes.
  • Gestation greater than or equal to 20 weeks established by the date of menstruation or by fetometry and ultrasound-confirmed late IUFD.

Exclusion Criteria:

  • Multiple pregnancies.
  • IUFD after late foeticide or the management of specific medical conditions associated with an increase in the risk of IUFD.
  • Patients with a history of hypertension.
  • Women with a history of unexplained antepartum haemorrhage, pelvic dystocia or any another counter-indications where medications were used.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02488642


Sponsors and Collaborators
National Institute of Perinatology
National Council of Science and Technology, Mexico
Investigators
Layout table for investigator information
Principal Investigator: Gabriel Arteaga-Troncoso, PhD. National Institute of Perinatology
Publications of Results:

Other Publications:
World Health Organization. Induction and augmentation of labour. In: WHO, UNFPA, UNICEF, World Bank, editor. Managing Complications in Pregnancy and Childbirth: A Guide for Midwives and Doctors. Geneva: WHO; 2000. pp. 17-25.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Gabriel Arteaga Troncoso, Medical Researcher, National Institute of Perinatology
ClinicalTrials.gov Identifier: NCT02488642    
Other Study ID Numbers: 212250-29021
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: July 24, 2015
Last Verified: July 2015
Keywords provided by Gabriel Arteaga Troncoso, National Institute of Perinatology:
Isosorbide dinitrate gel solution
late intrauterine death
nitric oxide donors
Additional relevant MeSH terms:
Layout table for MeSH terms
Fetal Death
Stillbirth
Death
Pathologic Processes
Pregnancy Complications
Isosorbide
Isosorbide Dinitrate
Isosorbide-5-mononitrate
Misoprostol
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action