IUD ComplicationNCT04718337
Postpartum Intra-caesarean Intrauterine Device Insertion Using a Novel Technique
An observational study of IUD Complication, run by Assiut University.
Trial summary
The assessment of efficacy and patient safety of immediate postpartum IUD insertion using a novel technique. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- IUD Complication
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Primary care clinic
Who may be able to join
- Women admitted to undergo CS.
- Singleton pregnancy.
- Delivery of a liveـborn infant with gestational age < 36 weeks.
- Informed and written consent to participate in the study.
Who cannot join
- History of dysmenorrhea, menorrhagia or coagulopathies.
- Uterine anomalies or fibroids.
- Antepartum or intrapartum hemorrhage.
- Prolonged rupture of membranes <24 hours with or without chorioamnionitis.
- Intrapartum fever.
- History of current, recent (within previous 3 months) or recurrent pelvic infilammatory diseases (PID).
Show all 10Show fewer
- History of ectopic pregnancy.
- Multiple pregnancy.
- Active cervicitis, vaginitis or sexual transmitted diseases (STD) on gyaecological examination.
- Allergy to any component of the IUD or Wilson's disease.
Trial locations and contacts
No sites are listed yet.
About this study
The assessment of efficacy and patient safety of immediate postpartum IUD insertion using a novel technique.
Read the detailed description
The postpartum period is so critical time for both the mother and newborn that needs special health care because there are high morbidity and mortality rates during it (1).
The World Health Organization (WHO) recommends that a woman should wait at least 24 months after delivery before the next pregnancy to decrease the adverse maternal, perinatal ,and infant outcomes (2, 3).
A woman's fertility may begin to return rapidly and ovulate within 4:6 weeks postpartum particularly if she is not exclusively breastfeeding. In addition , more than 50% of women become sexually active by 6 weeks postpartum (4, 5).
So, it is important to provide highly effective contraception immediately after delivery before leaving the delivery setting especially in communities where women cannot return easily for follow up visits due to financial and social barriers or who have limited access to medical service (6, 7).
The use of effective postpartum contraception particularly longـacting reversible contraception (LARC) methods like the intrauterine device (IUD) has been shown to decrease the risk of unintended pregnancy and its complications and avoid repeated caesarean sections with higher continuation rates of use than other methods 6 months after delivery (8-10).
Immediate post placental intraـcaesarean IUD insertion has many advantages as it is effective reversible longـterm contraception, doesn't interfere with breastfeeding, is coitus independent and the woman can avoid discomfort and pain during the standard insertion and bleeding from insertion will be masked by lochia (11-14).
Studies have shown that with effective provider training, the immediate postpartum IUD insertion (IPPIUD) complications such as expulsion, pelvic infection, bleeding, pain, missing threads ,and failure rates are not significantly different from those of interval PPIUD insertion (4:6 weeks) after delivery (15, 16).
By using a novel technique in this study, these complications would be decreased.
- Conditions
- IUD Complication
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of postpartum intra-caesaren IUD insertion
the evaluation of efficacy of this novel technique to decrease the rates of expulsion, missing threads and failure.
Measured: 6 months
Secondary outcomes (1)
Patient safety of postpartum intra-caesarean IUD insertion
the evaluation of patient safety including pelvic infections, lower abdominal pain and excessive bleeding.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Jun 2021 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IUD ComplicationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Tamer Laisha, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718337
- Sponsor's protocol ID
- Postpartum IUD insertion
- Status last verified
- Jan 2021
- First submitted
- 26 Sep 2020
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kumar M, Kumar M, Aggarwal P, Gangania A, Dewan. A study to evaluate and compare the expulsion and continuation rates of post placental insertion of Cu 375 and CuT 380A in Indian women at a premier hospital in New Delhi, India. Int J Reprod Contracept Obstet Gynecol 2017;6(9):3992-4000. Health WHODoM, Abuse S, Organization WH, Health WHODoM, Health SAM, Evidence WHOMH, et al. Mental health atlas 2005: World Health Organization; 2005. Rutstein S, Johnson K, Conde-Agudelo A, Rosas-Bermudez A. Effect of birth spacing on infant and child mortality: a systematic review and meta-analysis. WHO Technical Consultation and Scientific Review of Birth Spacing 2005;13(5). Jackson E, Glasier A. Return of ovulation and menses in postpartum nonlactating women: a systematic review. Obstet Gynecol 2011;117(3):657-662. Speroff L, Mishell DR. The postpartum visit: it's time for a change in order to optimally initiate contraception. Contraception 2008;78(2):90-98. Lucksom PG, Kanungo BK, Sebastian N, Mehrotra R, Pradhan D, Upadhya R. Comparative study of interval versus postpartum Cu-T insertion in a central referral hospital of North East India. Int J Reprod Contracept Obstet Gynecol 2015;4(1):47-51. DiBari JN, Yu SM, Chao SM, Lu MC. Use of postpartum care: predictors and barriers. Journal of pregnancy 2014;2014. Levi EE, Stuart GS, Zerden ML, Garrett JM, Bryant AG. Intrauterine device placement during cesarean delivery and continued use 6 months postpartum: a randomized controlled trial. Obstet Gynecol 2015;126(1):5-11. Organization WH. Report of a WHO technical consultation on birth spacing: Geneva, Switzerland 13-15 June 2005. World Health Organization; 2007. Obstetricians ACo, Obstetrics GJ, gynecology. ACOG Practice Bulletin No. 121: Long-acting reversible contraception: Implants and intrauterine devices. Obstetrics and Gynecology. 2011;118(1):184-196. Kapp N, Curtis KM. Intrauterine device insertion during the postpartum period: a systematic review. Contraception 2009;80(4):327-336. Glasier A. Best Practice in Postpartum Family Planning. Best Practice Paper No 1. June 2015. London: Royal College of Obstetricians and Gynaecologists; 2015. Heller R, Cameron S, Briggs R, Forson N, Glasier A. Postpartum contraception: a missed opportunity to prevent unintended pregnancy and short inter-pregnancy intervals. J Fam Plann Reprod Health Care 2016;42(2):93-98. Teal SB. Postpartum contraception: optimizing interpregnancy intervals. Contraception 2014;89(6):487-488. Grimes DA, Lopez LM, Schulz KF, Van Vliet HA, Stanwood NL. Immediate post-partum insertion of intrauterine devices. Cochrane Database Syst Rev 2010;(5):CD003036. Çelen Ş, Sucak A, Yıldız Y, Danışman N. Immediate postplacental insertion of an intrauterine contraceptive device during cesarean section. Contraception 2011;84(3):240-243. Zaconeta AM, Oliveira AC, Estrela FS, Vasconcelos TM, França PS, Wanderley MdS, Amato AA. Intrauterine device insertion during cesarean section in women without prenatal contraception counseling: lessons from a country with high cesarean rates. Revista Brasileira de Ginecolgia e Obstetricia 2019;41(8):485-492.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Intra-caesarean Intrauterine Device Insertion Using a Novel Technique
- ClinicalTrials.gov ID
- NCT04718337
- Acronym / sponsor ID
- Postpartum IUD insertion
- Conditions
- IUD Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The assessment of efficacy and patient safety of immediate postpartum IUD insertion using a novel technique.
Detailed description
The postpartum period is so critical time for both the mother and newborn that needs special health care because there are high morbidity and mortality rates during it (1).
The World Health Organization (WHO) recommends that a woman should wait at least 24 months after delivery before the next pregnancy to decrease the adverse maternal, perinatal ,and infant outcomes (2, 3).
A woman's fertility may begin to return rapidly and ovulate within 4:6 weeks postpartum particularly if she is not exclusively breastfeeding. In addition , more than 50% of women become sexually active by 6 weeks postpartum (4, 5).
So, it is important to provide highly effective contraception immediately after delivery before leaving the delivery setting especially in communities where women cannot return easily for follow up visits due to financial and social barriers or who have limited access to medical service (6, 7).
The use of effective postpartum contraception particularly longـacting reversible contraception (LARC) methods like the intrauterine device (IUD) has been shown to decrease the risk of unintended pregnancy and its complications and avoid repeated caesarean sections with higher continuation rates of use than other methods 6 months after delivery (8-10).
Immediate post placental intraـcaesarean IUD insertion has many advantages as it is effective reversible longـterm contraception, doesn't interfere with breastfeeding, is coitus independent and the woman can avoid discomfort and pain during the standard insertion and bleeding from insertion will be masked by lochia (11-14).
Studies have shown that with effective provider training, the immediate postpartum IUD insertion (IPPIUD) complications such as expulsion, pelvic infection, bleeding, pain, missing threads ,and failure rates are not significantly different from those of interval PPIUD insertion (4:6 weeks) after delivery (15, 16).
By using a novel technique in this study, these complications would be decreased.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Primary care clinic
Key inclusion criteria (4 listed)
- Women admitted to undergo CS.
- Singleton pregnancy.
- Delivery of a liveـborn infant with gestational age < 36 weeks.
- Informed and written consent to participate in the study.
Key exclusion criteria (10 listed)
- History of dysmenorrhea, menorrhagia or coagulopathies.
- Uterine anomalies or fibroids.
- Antepartum or intrapartum hemorrhage.
- Prolonged rupture of membranes <24 hours with or without chorioamnionitis.
- Intrapartum fever.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy of postpartum intra-caesaren IUD insertion
Time frame: 6 months
the evaluation of efficacy of this novel technique to decrease the rates of expulsion, missing threads and failure.
1 secondary outcome
Patient safety of postpartum intra-caesarean IUD insertion
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- BackgroundKumar M, Kumar M, Aggarwal P, Gangania A, Dewan. A study to evaluate and compare the expulsion and continuation rates of post placental insertion of Cu 375 and CuT 380A in Indian women at a premier hospital in New Delhi, India. Int J Reprod Contracept Obstet Gynecol 2017;6(9):3992-4000. Health WHODoM, Abuse S, Organization WH, Health WHODoM, Health SAM, Evidence WHOMH, et al. Mental health atlas 2005: World Health Organization; 2005. Rutstein S, Johnson K, Conde-Agudelo A, Rosas-Bermudez A. Effect of birth spacing on infant and child mortality: a systematic review and meta-analysis. WHO Technical Consultation and Scientific Review of Birth Spacing 2005;13(5). Jackson E, Glasier A. Return of ovulation and menses in postpartum nonlactating women: a systematic review. Obstet Gynecol 2011;117(3):657-662. Speroff L, Mishell DR. The postpartum visit: it's time for a change in order to optimally initiate contraception. Contraception 2008;78(2):90-98. Lucksom PG, Kanungo BK, Sebastian N, Mehrotra R, Pradhan D, Upadhya R. Comparative study of interval versus postpartum Cu-T insertion in a central referral hospital of North East India. Int J Reprod Contracept Obstet Gynecol 2015;4(1):47-51. DiBari JN, Yu SM, Chao SM, Lu MC. Use of postpartum care: predictors and barriers. Journal of pregnancy 2014;2014. Levi EE, Stuart GS, Zerden ML, Garrett JM, Bryant AG. Intrauterine device placement during cesarean delivery and continued use 6 months postpartum: a randomized controlled trial. Obstet Gynecol 2015;126(1):5-11. Organization WH. Report of a WHO technical consultation on birth spacing: Geneva, Switzerland 13-15 June 2005. World Health Organization; 2007. Obstetricians ACo, Obstetrics GJ, gynecology. ACOG Practice Bulletin No. 121: Long-acting reversible contraception: Implants and intrauterine devices. Obstetrics and Gynecology. 2011;118(1):184-196. Kapp N, Curtis KM. Intrauterine device insertion during the postpartum period: a systematic review. Contraception 2009;80(4):327-336. Glasier A. Best Practice in Postpartum Family Planning. Best Practice Paper No 1. June 2015. London: Royal College of Obstetricians and Gynaecologists; 2015. Heller R, Cameron S, Briggs R, Forson N, Glasier A. Postpartum contraception: a missed opportunity to prevent unintended pregnancy and short inter-pregnancy intervals. J Fam Plann Reprod Health Care 2016;42(2):93-98. Teal SB. Postpartum contraception: optimizing interpregnancy intervals. Contraception 2014;89(6):487-488. Grimes DA, Lopez LM, Schulz KF, Van Vliet HA, Stanwood NL. Immediate post-partum insertion of intrauterine devices. Cochrane Database Syst Rev 2010;(5):CD003036. Çelen Ş, Sucak A, Yıldız Y, Danışman N. Immediate postplacental insertion of an intrauterine contraceptive device during cesarean section. Contraception 2011;84(3):240-243. Zaconeta AM, Oliveira AC, Estrela FS, Vasconcelos TM, França PS, Wanderley MdS, Amato AA. Intrauterine device insertion during cesarean section in women without prenatal contraception counseling: lessons from a country with high cesarean rates. Revista Brasileira de Ginecolgia e Obstetricia 2019;41(8):485-492.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of IUD Complication, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine T Laisha (01069194366 ext. 0882500729, christinetamer987@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of postpartum intra-caesaren IUD insertion (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04718337, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.