Vaginal Dinoprostone Administration Prior to a T380A Intrauterine Device Insertion in Nulliparous Women.

Cairo University200 enrolled

Overview

To investigate whether vaginal dinoprostone administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications and pain in nulliparous women.

Women may experience pain and technical difﬁculties may be encountered when insertion of an intrauterine device (IUD) is attempted through a narrow cervical canal.IUD insertion- related complications and side effects are more common among women who had never delivered vaginally.n American College of Obstetricians and Gynecologists committee opinion encourages providers to use IUDs as a ﬁrst line of contraception in nulliparous women.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

200

Conditions

Intrauterine Device

Interventions

Dinoprostone 3 mgDRUG

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 6 hours before IUD insertion.

placebo vaginal tabletDRUG

1 vaginal tablet of placebo inserted by the study nurse 6 hours before IUD insertion.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Nulliparous women aged over 18 years of age requesting a copper IUD for contraception, had a negative pregnancy test. Exclusion Criteria: * • a prior pregnancy greater than 20 weeks of duration * currently pregnant or were pregnant within 6 weeks of study entry * had a prior attempted or successful IUD insertion * had a history of a cervical procedure such as cone biopsy, Loop electrosurgical excision procedure, or cryotherapy * any World Health Organization Medical Eligibility Criteria category 3 or 4 precaution to an IUD * active vaginitis or cervicitis * undiagnosed abnormal uterine bleeding * pelvic inﬂammatory disease within the last 3 months * ﬁbroids or other uterine abnormalities distorting the uterine cavity * contraindication to dinoprostone.

Locations (1)

Faculty of Medicine Cairo University

Giza, Egypt

Outcomes

Primary Outcomes

Provider ease of insertion

Provider ease of insertion was evaluated using a visual analog scale from 0 to 10 cm where 0 denotes very easy insertion and 10 denotes a very difficult insertion.

Time frame: 5 minutes

Secondary Outcomes

the difference in the pain intensity scores between the study groups

the difference in the pain intensity scores between the study groups at IUD insertion BY10 cm visual analog scale score where 0 denotes no pain and 10 denotes the most imaginable pain

Time frame: 5 minutes

insertion time

IUD insertion time from speculum in to speculum out

Time frame: 10 minutes

Data from ClinicalTrials.gov

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