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Puerperal and menstrual bleeding patterns after two types of contraceptive devices fitted during elective cesarean section.

Puerperal and menstrual bleeding patterns after two types of contraceptive devices fitted during elective cesarean section.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000983909
Enrollment
180
Registered
2011-09-15
Start date
2007-01-01
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

to test the feasibility, safety, and efficacy of contraceptive devices fitting during elective cesarean delivery as well as the impact of this intervention on peurperal and menstrual blood loss.

Interventions

There are a total of three groups in this study (a) Copper containing intra-uterine contraceptive device (IUCD) inserted during cesarean section (C.S.) for future contraception, (b) Levonorgestrel containing device inserted for the same indication and (c) Cesarean section without device insertion. Copper containing contraceptive device is the standard IUD used for birth control while Levonorgestrel containing intra-uterine system (IUS) is a newer intrauterine contraceptive device with a steroid

There are a total of three groups in this study (a) Copper containing intra-uterine contraceptive device (IUCD) inserted during cesarean section (C.S.) for future contraception, (b) Levonorgestrel containing device inserted for the same indication and (c) Cesarean section without device insertion. Copper containing contraceptive device is the standard IUD used for birth control while Levonorgestrel containing intra-uterine system (IUS) is a newer intrauterine contraceptive device with a steroid reservoir that releases 20 micrograms of levonorgestrel daily. Insertion during cesarean section, requires one minute to perform to be removed on patient request or after expiry of the device (5 years for levonorgestrel device, and 10 years for IUCD), however the duration of follow-up in the study is only 18 months.

Sponsors

Mervat Sheikh Elarab Elsedeek Omran
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
Yes

Inclusion criteria

healthy women, with full-term pregnancy, undergoing elective cesarean delivery, with no medical problems, normal uterus.

Exclusion criteria

labor pains, multiple pregnancy, medical problems, uterine pathology.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026