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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03686085

Enrollment

200

Registered

2018-09-26

Start date

2018-09-30

Completion date

2019-03-10

Last updated

2020-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrauterine Device

Brief summary

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

Detailed description

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.

Interventions

DRUGDinoprostone 3 mg

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

DRUGplacebo vaginal tablet

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Provider ease of insertion	5 minutes	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.

Secondary

Measure	Time frame	Description
the difference in the pain intensity scores between the study groups	5 minutes	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
insertion time	10 minutes	IUD insertion time from speculum in to speculum out

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026