Scar NicheT380ANCT07264933
Postplacental Copper Intrauterine Device Versus Postpartum Progesterone-only Pills on Uterine Niche Formation
A study testing Primary Cesarean Section, immediate postplacental insertion of a copper T380A intrauterine device and progesterone-only pills in people with Scar Niche and Myometrial Remodeling, run by Benha University at 1 site in Egypt.
Trial summary
The purpose of the study is to determine whether immediate postplacental copper T380A intrauterine device insertion increases uterine-niche incidence compared with postpartum progestin-only pills after primary cesarean section . Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Scar Niche, Myometrial Remodeling, Contraceptive Device; Complications
- What is being tested?
- Primary Cesarean Section, immediate postplacental insertion of a copper T380A intrauterine device and progesterone-only pills
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Feb 2025to 5 Feb 2026
- Phase
- Interventional
- 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
Who may be able to join
- primigravida with a gestational age of ≥37 weeks
- express a desire for postpartum contraception.
- acceptance to participate and to provide written informed consent
- willing to attend follow-up for 6 months postpartum.
Who cannot join
- Known uterine anomalies
- Chorioamnionitis
- Premature rupture of membranes > 24 hours
- Previous uterine surgery
- Cervical dysplasia
- Uterine fibroids
Show all 14Show fewer
- Multiple gestation
- Placenta previa or placental abruption
- Preeclampsia or eclampsia
- Hemoglobin < 10 g/dL
- Any uncontrolled systemic disease
- Current tobacco use
- Chronic corticosteroid therapy
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Immediate Postplacental Copper T380A Intrauterine Device Insertion Versus Postpartum Progesterone-only Pills on Uterine Niche Formation After Primary Cesarean Section: a Prospective, Open-label Randomized Controlled Trial
The purpose of the study is to determine whether immediate postplacental copper T380A intrauterine device insertion increases uterine-niche incidence compared with postpartum progestin-only pills after primary cesarean section .
Read the detailed description
Eligible primigravida participants aged 18-45 years with a gestational age of ≥37 weeks undergoing a primary cesarean section for any indication were required to provide written informed consent, agree to attend follow-up visits for 6 months postpartum, and express a desire for postpartum contraception. After confirming eligibility and obtaining consent, a trained nurse selected an envelope for each patient and revealed the allocation to the patient and the operating obstetrician. Participants were randomized1:1 to either immediate postplacental insertion of copper T380A intrauterine device performed intraoperatively using the standardized intracesarean introducer-withdrawal technique or not to receive an intraoperative intrauterine device but they were instructed to initiate progesterone-only pills 4 weeks postpartum and at least 5 days before resuming sexual activity, till at least the end of 6th month postpartum. All lower-segment cesarean sections were performed by qualified obstetricians at Benha University Hospitals who were trained on the study protocol. The standard Kerr technique was used for the uterine incision, followed by double-layer continuous myometrial closure with braided polyglycolic acid 0-1 sutures, ensuring decidual sparing and visceral peritoneum closure. Follow-up visits were scheduled at 3 and 6 months postpartum.
- Ultrasound Assessment: Two independent, trained sonographers-blinded to each other's findings-perform transvaginal ultrasound examinations in both sagittal and coronal planes. At 3 and 6 months postpartum,intrauterine device displacement is considered if the distance between the dome of the uterine cavity to the upper part of the intrauterine device is > 3 mm and these participants will be provided with another method of contraception according to their wish and will be excluded from the final analysis . At 3 and 6 months postpartum, a niche is defined as an indentation ≥2 mm in the myometrium at the previous cesarean scar site. At 6 months postpartum uterine niche depth, length, width and residual myometrial thickness are to be recorded .
- Clinical Assessment: A separate obstetrician/gynecologist will collect data on menstrual patterns and breastfeeding initiation and continuation .
- Conditions
- Scar Niche, Myometrial Remodeling, Contraceptive Device; Complications, Cesarean Section Complications
- Being tested
- Primary Cesarean Section, immediate postplacental insertion of a copper T380A intrauterine device, progesterone-only pills, Transvaginal ultrasound
- Keywords
- Primary cesarean section, intrauterine device, post placental copper T380A, uterine niche, residual myometrial thickness, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Cesarean SectionProcedure or surgery
All lower-segment cesarean sections were performed by qualified obstetricians at Benha University Hospitals who were trained on the study protocol. The standard Kerr technique was used for the uterine incision, followed by double-layer continuous myometrial closure with braided polyglycolic acid 0-1 sutures, with decidual sparing and visceral peritoneal closure.
immediate postplacental insertion of a copper T380A intrauterine deviceDevice
immediate postplacental insertion of a copper T380A intrauterine device was performed intraoperatively using the standardized intracesarean introducer-withdrawal technique. The intrauterine device introducer with the intrauterine device threads inside is trimmed to 12 cm. The uterus is held and stabilized with the non-dominant hand, and the introducer is inserted first downwards through the cervical canal before pushing it up to put it firmly against the endometrium of the uterine fundus. Then, it is pulled gently down through the cervical canal to the vagina while pressing on the fundus with the non-dominant hand, thus ensuring that the intrauterine device is kept at the fundus and that the intrauterine device threads are in the cervical canal. the introducer is removed gently manually from the vagina at the end of the cesarean section after closure of the skin and ceiling of the wound .
progesterone-only pillsDrug
Also called Microlut®; Bayer
Participants were instructed to initiate daily oral intake of progesterone-only pills containing 0.03 mg levonorgestrel per pill (Microlut®; Bayer) at 4 weeks postpartum and at least 5 days before resuming sexual activity. The participants were asked to use it continuously at least till the end of the 6th month postpartum. This product is commercially available in Egypt and contains 35 active tablets per pack.
Transvaginal ultrasoundDiagnostic test
Two independent, trained sonographers-blinded to each other's findings- will perform transvaginal ultrasound examinations in both sagittal and coronal planes. At 3 and 6 months postpartum,intrauterine device displacement is considered if the distance between the dome of the uterine cavity to the upper part of the intrauterine device is > 3 mm and these participants will be excluded from the final analysis . At 3 and 6 months postpartum, a niche is defined as an indentation ≥2 mm in the myometrium at the previous cesarean scar site. At 6 months postpartum uterine niche depth, length, width and residual myometrial thickness are to be recorded .
| Study group | Role | What they receive |
|---|---|---|
| Immediate postplacental copper T380A intrauterine device | Active comparator | In the Study group, immediate postplacental insertion of a copper T380A intrauterine device was performed intraoperatively using the standardized intracesarean introducer-withdrawal technique. Receives: Procedure: Primary Cesarean Section; Device: immediate postplacental insertion of a copper T380A intrauterine device; Diagnostic Test: Transvaginal ultrasound |
| Postpartum progesterone-only pills | Active comparator | In the control group, participants did not receive an intraoperative intrauterine device . They were instructed to initiate daily oral intake of progesterone-only pills at 4 weeks postpartum and at least 5 days before resuming sexual activity and to continue using it till at least the end of the sixth month postpartum. Receives: Procedure: Primary Cesarean Section; Drug: progesterone-only pills; Diagnostic Test: Transvaginal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of uterine niche formation after primary cesarean section.
using transvaginal ultrasound (2D, sagittal and coronal views), a niche is defined as an indentation ≥2 mm in the myometrium at the previous cesarean scar site
Measured: at 3 and 6 months postpartum
Secondary outcomes (4)
Rate of intrauterine device displacement
Among the immediate postplacental copper T380A intrauterine device insertion group of participants, ,intrauterine device displacement is considered if the distance between the dome of the uterine cavity to the upper part of the intrauterine device is > 3 mm on transvaginal ultrasound examination.
Measured: At 3 and 6 months postpartum
Uterine niche measurements.
In participants with niche diagnosed using transvaginal ultrasound (2D, sagittal and coronal views), uterine niche depth, length, width and residual myometrial thickness are to be recorded.
Measured: At 6 months postpartum
Menstrual bleeding outcomes in participants with uterine niche.
A separate obstetrician/gynecologist will collect data on menstrual patterns in participants with uterine niche in both groups including amenorrhea, postmenstrual / intermenstrual spotting and total bleeding days per cycle
Measured: At 6 months postpartum
Breastfeeding outcomes.
A separate obstetrician/gynecologist will collect data on breastfeeding outcomes in both groups including initiation and continuation of breast feeding.
Measured: At 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start12 Feb 2025
- Primary completion5 Aug 2025
- Study completion5 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Scar NicheStudies of the same condition, open and under way.
- More trials run by Benha 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdel Latif Ahmed Alnezamy, Benha University
- Investigators
- AHMED ALNEZAMY, MD, Principal investigator, Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264933
- Sponsor's protocol ID
- RC12-2-2025
- Acronym
- T380A
- Status last verified
- Feb 2026
- First submitted
- 23 Nov 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Committee on Practice Bulletins-Gynecology, Long-Acting Reversible Contraception Work Group. Practice Bulletin No. 186: Long-Acting Reversible Contraception: Implants and Intrauterine Devices. Obstet Gynecol. 2017 Nov;130(5):e251-e269. doi: 10.1097/AOG.0000000000002400.
PubMed 29064972Wu M, Eisenberg R, Negassa A, Levi E. Associations between immediate postpartum long-acting reversible contraception and short interpregnancy intervals. Contraception. 2020 Dec;102(6):409-413. doi: 10.1016/j.contraception.2020.08.016. Epub 2020 Sep 10.
PubMed 32918870Jordans IPM, de Leeuw RA, Stegwee SI, Amso NN, Barri-Soldevila PN, van den Bosch T, Bourne T, Brolmann HAM, Donnez O, Dueholm M, Hehenkamp WJK, Jastrow N, Jurkovic D, Mashiach R, Naji O, Streuli I, Timmerman D, van der Voet LF, Huirne JAF. Sonographic examination of uterine niche in non-pregnant women: a modified Delphi procedure. Ultrasound Obstet Gynecol. 2019 Jan;53(1):107-115. doi: 10.1002/uog.19049.
PubMed 29536581Klein Meuleman SJM, Min N, Hehenkamp WJK, Post Uiterweer ED, Huirne JAF, de Leeuw RA. The definition, diagnosis, and symptoms of the uterine niche - A systematic review. Best Pract Res Clin Obstet Gynaecol. 2023 Aug;90:102390. doi: 10.1016/j.bpobgyn.2023.102390. Epub 2023 Jul 15.
PubMed 37506497Doulaveris G, Jou J, Leung WK, Bircaj E, Orfanelli T, Atrio J, Dar P, Rotenberg O. Association of Intrauterine Device Malposition With Previous Cesarean Delivery and Related Uterine Anatomical Changes. J Ultrasound Med. 2024 Jun;43(6):1121-1129. doi: 10.1002/jum.16440. Epub 2024 Feb 29.
PubMed 38421056Seleem M, Sedik MM, Megahed AMM, Nabil H. Conventional manual technique of post placental IUD insertion versus intra-cesarean post placental introducer withdrawal IUD insertion technique: a new standardized technique for IUD insertion during cesarean section: a randomized controlled trial. BMC Pregnancy Childbirth. 2023 Jun 26;23(1):474. doi: 10.1186/s12884-023-05777-1.
PubMed 37365489Osser OV, Jokubkiene L, Valentin L. Cesarean section scar defects: agreement between transvaginal sonographic findings with and without saline contrast enhancement. Ultrasound Obstet Gynecol. 2010 Jan;35(1):75-83. doi: 10.1002/uog.7496.
PubMed 20034000Levi 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 Jul;126(1):5-11. doi: 10.1097/AOG.0000000000000882.
PubMed 26241250
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Immediate Postplacental Copper T380A Intrauterine Device Insertion Versus Postpartum Progesterone-only Pills on Uterine Niche Formation After Primary Cesarean Section: a Prospective, Open-label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07264933
- Acronym / sponsor ID
- T380A / RC12-2-2025
- Conditions
- Scar Niche, Myometrial Remodeling, Contraceptive Device; Complications, Cesarean Section Complications
- Keywords
- Primary cesarean section, intrauterine device, post placental copper T380A, uterine niche, residual myometrial thickness, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 5 Aug 2025 (actual)
- Study completion
- 5 Feb 2026 (actual)
- First posted
- 4 Dec 2025 (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 purpose of the study is to determine whether immediate postplacental copper T380A intrauterine device insertion increases uterine-niche incidence compared with postpartum progestin-only pills after primary cesarean section .
Detailed description
Eligible primigravida participants aged 18-45 years with a gestational age of ≥37 weeks undergoing a primary cesarean section for any indication were required to provide written informed consent, agree to attend follow-up visits for 6 months postpartum, and express a desire for postpartum contraception. After confirming eligibility and obtaining consent, a trained nurse selected an envelope for each patient and revealed the allocation to the patient and the operating obstetrician. Participants were randomized1:1 to either immediate postplacental insertion of copper T380A intrauterine device performed intraoperatively using the standardized intracesarean introducer-withdrawal technique or not to receive an intraoperative intrauterine device but they were instructed to initiate progesterone-only pills 4 weeks postpartum and at least 5 days before resuming sexual activity, till at least the end of 6th month postpartum. All lower-segment cesarean sections were performed by qualified obstetricians at Benha University Hospitals who were trained on the study protocol. The standard Kerr technique was used for the uterine incision, followed by double-layer continuous myometrial closure with braided polyglycolic acid 0-1 sutures, ensuring decidual sparing and visceral peritoneum closure. Follow-up visits were scheduled at 3 and 6 months postpartum.
- Ultrasound Assessment: Two independent, trained sonographers-blinded to each other's findings-perform transvaginal ultrasound examinations in both sagittal and coronal planes. At 3 and 6 months postpartum,intrauterine device displacement is considered if the distance between the dome of the uterine cavity to the upper part of the intrauterine device is > 3 mm and these participants will be provided with another method of contraception according to their wish and will be excluded from the final analysis . At 3 and 6 months postpartum, a niche is defined as an indentation ≥2 mm in the myometrium at the previous cesarean scar site. At 6 months postpartum uterine niche depth, length, width and residual myometrial thickness are to be recorded .
- Clinical Assessment: A separate obstetrician/gynecologist will collect data on menstrual patterns and breastfeeding initiation and continuation .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate postplacental copper T380A intrauterine device | Active comparator | Procedure: Primary Cesarean Section, Device: immediate postplacental insertion of a copper T380A intrauterine device, Diagnostic Test: Transvaginal ultrasoundIn the Study group, immediate postplacental insertion of a copper T380A intrauterine device was performed intraoperatively using the standardized intracesarean introducer-withdrawal technique. |
| Postpartum progesterone-only pills | Active comparator | Procedure: Primary Cesarean Section, Drug: progesterone-only pills, Diagnostic Test: Transvaginal ultrasoundIn the control group, participants did not receive an intraoperative intrauterine device . They were instructed to initiate daily oral intake of progesterone-only pills at 4 weeks postpartum and at least 5 days before resuming sexual activity and to continue using it till at least the end of the sixth month postpartum. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- primigravida with a gestational age of ≥37 weeks
- express a desire for postpartum contraception.
- acceptance to participate and to provide written informed consent
- willing to attend follow-up for 6 months postpartum.
Key exclusion criteria (14 listed)
- Known uterine anomalies
- Chorioamnionitis
- Premature rupture of membranes > 24 hours
- Previous uterine surgery
- Cervical dysplasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary Cesarean SectionAll lower-segment cesarean sections were performed by qualified obstetricians at Benha University Hospitals who were trained on the study protocol. The standard Kerr technique was used for the uterine incision, followed by double-layer continuous myometrial closure with braided polyglycolic acid 0-1 sutures, with decidual sparing and visceral peritoneal closure. | Procedure or surgery | Immediate postplacental copper T380A intrauterine device, Postpartum progesterone-only pills |
| immediate postplacental insertion of a copper T380A intrauterine deviceimmediate postplacental insertion of a copper T380A intrauterine device was performed intraoperatively using the standardized intracesarean introducer-withdrawal technique. The intrauterine device introducer with the intrauterine device threads inside is trimmed to 12 cm. The uterus is held and stabilized with the non-dominant hand, and the introducer is inserted first downwards through the cervical canal before pushing it up to put it firmly against the endometrium of the uterine fundus. Then, it is pulled gently down through the cervical canal to the vagina while pressing on the fundus with the non-dominant hand, thus ensuring that the intrauterine device is kept at the fundus and that the intrauterine device threads are in the cervical canal. the introducer is removed gently manually from the vagina at the end of the cesarean section after closure of the skin and ceiling of the wound . | Device | Immediate postplacental copper T380A intrauterine device |
| progesterone-only pillsAlso: Microlut®; BayerParticipants were instructed to initiate daily oral intake of progesterone-only pills containing 0.03 mg levonorgestrel per pill (Microlut®; Bayer) at 4 weeks postpartum and at least 5 days before resuming sexual activity. The participants were asked to use it continuously at least till the end of the 6th month postpartum. This product is commercially available in Egypt and contains 35 active tablets per pack. | Drug | Postpartum progesterone-only pills |
| Transvaginal ultrasoundTwo independent, trained sonographers-blinded to each other's findings- will perform transvaginal ultrasound examinations in both sagittal and coronal planes. At 3 and 6 months postpartum,intrauterine device displacement is considered if the distance between the dome of the uterine cavity to the upper part of the intrauterine device is > 3 mm and these participants will be excluded from the final analysis . At 3 and 6 months postpartum, a niche is defined as an indentation ≥2 mm in the myometrium at the previous cesarean scar site. At 6 months postpartum uterine niche depth, length, width and residual myometrial thickness are to be recorded . | Diagnostic test | Immediate postplacental copper T380A intrauterine device, Postpartum progesterone-only pills |
Primary outcome
Rate of uterine niche formation after primary cesarean section.
Time frame: at 3 and 6 months postpartum
using transvaginal ultrasound (2D, sagittal and coronal views), a niche is defined as an indentation ≥2 mm in the myometrium at the previous cesarean scar site
4 secondary outcomes
Rate of intrauterine device displacement
Time frame: At 3 and 6 months postpartum
Uterine niche measurements.
Time frame: At 6 months postpartum
Menstrual bleeding outcomes in participants with uterine niche.
Time frame: At 6 months postpartum
Breastfeeding outcomes.
Time frame: At 6 months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Background: PubMed 29064972Committee on Practice Bulletins-Gynecology, Long-Acting Reversible Contraception Work Group. Practice Bulletin No. 186: Long-Acting Reversible Contraception: Implants and Intrauterine Devices. Obstet Gynecol. 2017 Nov;130(5):e251-e269. doi: 10.1097/AOG.0000000000002400.
- Background: PubMed 32918870Wu M, Eisenberg R, Negassa A, Levi E. Associations between immediate postpartum long-acting reversible contraception and short interpregnancy intervals. Contraception. 2020 Dec;102(6):409-413. doi: 10.1016/j.contraception.2020.08.016. Epub 2020 Sep 10.
- Background: PubMed 29536581Jordans IPM, de Leeuw RA, Stegwee SI, Amso NN, Barri-Soldevila PN, van den Bosch T, Bourne T, Brolmann HAM, Donnez O, Dueholm M, Hehenkamp WJK, Jastrow N, Jurkovic D, Mashiach R, Naji O, Streuli I, Timmerman D, van der Voet LF, Huirne JAF. Sonographic examination of uterine niche in non-pregnant women: a modified Delphi procedure. Ultrasound Obstet Gynecol. 2019 Jan;53(1):107-115. doi: 10.1002/uog.19049.
- Background: PubMed 37506497Klein Meuleman SJM, Min N, Hehenkamp WJK, Post Uiterweer ED, Huirne JAF, de Leeuw RA. The definition, diagnosis, and symptoms of the uterine niche - A systematic review. Best Pract Res Clin Obstet Gynaecol. 2023 Aug;90:102390. doi: 10.1016/j.bpobgyn.2023.102390. Epub 2023 Jul 15.
- Background: PubMed 38421056Doulaveris G, Jou J, Leung WK, Bircaj E, Orfanelli T, Atrio J, Dar P, Rotenberg O. Association of Intrauterine Device Malposition With Previous Cesarean Delivery and Related Uterine Anatomical Changes. J Ultrasound Med. 2024 Jun;43(6):1121-1129. doi: 10.1002/jum.16440. Epub 2024 Feb 29.
- Results publication: PubMed 37365489Seleem M, Sedik MM, Megahed AMM, Nabil H. Conventional manual technique of post placental IUD insertion versus intra-cesarean post placental introducer withdrawal IUD insertion technique: a new standardized technique for IUD insertion during cesarean section: a randomized controlled trial. BMC Pregnancy Childbirth. 2023 Jun 26;23(1):474. doi: 10.1186/s12884-023-05777-1.
- Results publication: PubMed 20034000Osser OV, Jokubkiene L, Valentin L. Cesarean section scar defects: agreement between transvaginal sonographic findings with and without saline contrast enhancement. Ultrasound Obstet Gynecol. 2010 Jan;35(1):75-83. doi: 10.1002/uog.7496.
- Results publication: PubMed 26241250Levi 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 Jul;126(1):5-11. doi: 10.1097/AOG.0000000000000882.
- 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.
AHMED ALNEZAMY, MD principal investigator
Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Cesarean Section, immediate postplacental insertion of a copper T380A intrauterine device and progesterone-only pills in people with Scar Niche and Myometrial Remodeling, run by Benha University at 1 site in Egypt.
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 14 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: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of uterine niche formation after primary cesarean section. (time frame: at 3 and 6 months postpartum). 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 NCT07264933, which also lists 8 linked publications.
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 27 Feb 2026.