跳至主要内容
临床试验/NCT03049592
NCT03049592已完成不适用

High-risk Obstetrical Patient Intervention to Promote Birth Interval Spacing Utilizing the Contraceptive CHOICE Project Script to Reduce Unintended Subsequent Pregnancies

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Utilization of LARC

研究概览

简要总结

High-risk obstetrical patient Intervention to promote Birth Interval Spacing utilizing the Contraceptive CHOICE project script to reduce Unintended Subsequent pregnancies (HIBISCUS) is a collaborative study utilizing qualitative methods to assess the acceptability including a family planning specialist's postpartum contraception counseling during and after prenatal care among Latina obstetric women with pre-gestational diabetes. The investigators will compare the effectiveness of HIBISCUS versus usual contraceptive counseling on Long-Acting Reversible Contraception (LARC) use at 3 months postpartum.

详细描述

The purpose of this research is to address this gap in long-acting reversible contraception (LARC) counseling among Latinas who have pregnancies complicated by pre-gestational diabetes in order to promote optimal birth-to-pregnancy spacing and planned pregnancies with optimal glucose control. The investigators will utilize Contraceptive CHOICE project which was LARC focused counseling script and removed the cost of contraception. This study had a LARC utilization of 75% compared to the national use of LARC of 7.2% The investigators will conduct a pilot randomized controlled trial among Latina obstetrics patients with pre-gestational diabetes involving a prenatal and postpartum visit with a family planning specialist versus usual contraceptive counseling. The family planning specialist counseling will utilize the Contraceptive CHOICE Project script promoting LARC, 18 month birth-to-pregnancy recommendation and preconception counseling. The intervention's name is HIBISCUS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Latina obstetric women
  • Pre-gestational diabetes
  • Obtaining prenatal care in the high-risk obstetrical clinic - Diabetes in Pregnancy

排除标准

  • Desires sterilization

研究组 & 干预措施

HIBISCUS counseling

Experimental

Subject receives a third trimester prenatal appointment with a family planning specialist for contraceptive counseling (utilizing the Contraceptive CHOICE counseling script emphasizing the WHO birth-to-pregnancy recommendation of 18 months) and a follow up postpartum contraception visit with a family planning specialist.

干预措施: HIBISCUS counseling (Other)

Standard counseling

No Intervention

Subect receives standard high-risk prenatal care and postpartum contraception provision by the referring community clinic. The community clinic offer standard family planning counseling that does not emphasize utilizing of long-acting reversible contraception to promote birth-to-pregnancy spacing of 18 months. This scenario is current the standard practice at the institutions.

结局指标

主要结局

Utilization of LARC

时间窗: 1 year

Utilization of LARC postpartum

次要结局

  • Acceptability of contraceptive counseling intervention by patients and clinicians(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sheila Mody

Assistant Professor

University of California, San Diego

研究点 (2)

Loading locations...

相似试验

High-risk Obstetrical Patient Intervention Utilizing... | 临床试验