New Method of IUD Insertion During Cesarian Section

NCT ID: NCT05756998

Last Updated: 2023-03-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-02
• Study Completion Date: 2023-03-15

Brief Summary

In women undergoing elective CS, half of them will have Intra-caesarian copper T 380 IUD insertion using the standard method and the remaining half will undergo copper T 380 IUD insertion during CS using a new technique in order to detect which technique is more effective in having more accurate IUD position with visible threads.

Detailed Description

Intrauterine device (IUD) is considered one of the most acceptable and effective contraceptive methods used. It is widely accepted and used in Egypt at a large scale than any other type of contraception with many advantages over the other types of contraceptive methods including long acting hormonal methods . Despite IUD complications, it remains the most accepted method, as it has many advantages like being non-coital related, had no systemic complications, of long duration and reversible with rapid return of fertility after its removal . The complications of IUD include heavy menstrual bleedings, menstrual irregularities and infection complications which could be minimized by using strict aseptic techniques during insertion . The most distressing complication is the displacement of IUD, especially if this displacement was extra-uterine, as the patient needs a surgical maneuver (endoscopic usually) for extraction of this IUD. Displacement of IUDs puts a financial and psychological burden to the patient also increases the risk of unwanted pregnancies and its related risks . Displacement of IUD occurs mainly during its insertion, and occurs mainly due to rough or wrong technique; also IUD insertion at a wrong timing may increase risk of IUD displacement. So it is very important to insert IUDs at the proper time with the proper technique . Timing of insertion of IUD after cesarean section is a matter of debate, some gynecologists insert IUDs during cesarean section after placental removal, while other gynecologists prefer insertion of IUDs after an interval either immediately after puerprium (42 days), or after 6 months post-cesarean section, but the majority inserts IUDs after 3 months from cesarean section . The idea of waiting a three-month interval after cesarean section is to assure that the scar had completely healed and the uterus involutes completely to its pre-pregnancy size. The drawbacks of waiting this long interval are poor accessibility of the cervix which may be pulled upward in some cases of repeated cesarean section and loss of self-enthusiasm for rapid contraception after delivery .

Conditions

Postpartum Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: QUADRUPLE

Study Groups

classic technique

Group Type: ACTIVE_COMPARATOR

Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) (classic technique)

Intervention Type: DEVICE

During CS , placement of CuT380 IUD at the top of the uterine fundus with ring forceps or manually; before closing the uterine incision, the strings were placed in the lower uterine segment. If the cervix was closed, dilatation from above with ring forceps or manually. Strings passed through the cervix with ring forceps, then checking that IUD remains at the fundus of the uterus prior to closing the uterine incision. The surgeon took a good care not to include IUD strings within the sutures. Six weeks postpartum; Patients will be questioned for any symptoms of complications or side effects. Pelvic examination (per speculum) and transvaginal ultrasound will be performed. Patient satisfaction will be assessed: pain using (VAS score), missed threads.

cesarian section

Intervention Type: PROCEDURE

Under general or spinal anathesia , the abdomen is opened in layers , the bladder is dissected downwards . The uterus is incised at its lower segment \& the fetus is extracted , followed by the placenta \& membranes . The CU T 380 IUD is inserted either by the classic technique or the standard technique . The uterus is closed in 2 layers by continous non - locked sutures .Proper hemostasis \& closure of the abdomen in layers .

new technique

Group Type: EXPERIMENTAL

Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) ( New technique)

Intervention Type: DEVICE

During CS, the plunger will be removed, the introducer remains in place and the arms of the IUD were released to be in a transverse position. The introducer will be inserted in the cervical canal through the uterine incision, threads might be shortened if needed or if couldn't be advanced into the cervical canal, The introducer containing the IUD will be then pushed upwards , towards the uterine fundus.The IUD will be placed at the uterine fundus and the IUD will be stabilized at its fundal position by grasping the fundus between the thumb anteriorly and the other fingers posteriorly. The uterine incision was closed while the introducer is in situ , then the introducer will be removed vaginally at the end of CS. Six weeks postpartum; Patients will be followed as in the classic technique group.

cesarian section

Intervention Type: PROCEDURE

Under general or spinal anathesia , the abdomen is opened in layers , the bladder is dissected downwards . The uterus is incised at its lower segment \& the fetus is extracted , followed by the placenta \& membranes . The CU T 380 IUD is inserted either by the classic technique or the standard technique . The uterus is closed in 2 layers by continous non - locked sutures .Proper hemostasis \& closure of the abdomen in layers .

Interventions

Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) (classic technique)

During CS , placement of CuT380 IUD at the top of the uterine fundus with ring forceps or manually; before closing the uterine incision, the strings were placed in the lower uterine segment. If the cervix was closed, dilatation from above with ring forceps or manually. Strings passed through the cervix with ring forceps, then checking that IUD remains at the fundus of the uterus prior to closing the uterine incision. The surgeon took a good care not to include IUD strings within the sutures. Six weeks postpartum; Patients will be questioned for any symptoms of complications or side effects. Pelvic examination (per speculum) and transvaginal ultrasound will be performed. Patient satisfaction will be assessed: pain using (VAS score), missed threads.

Intervention Type: DEVICE

Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) ( New technique)

During CS, the plunger will be removed, the introducer remains in place and the arms of the IUD were released to be in a transverse position. The introducer will be inserted in the cervical canal through the uterine incision, threads might be shortened if needed or if couldn't be advanced into the cervical canal, The introducer containing the IUD will be then pushed upwards , towards the uterine fundus.The IUD will be placed at the uterine fundus and the IUD will be stabilized at its fundal position by grasping the fundus between the thumb anteriorly and the other fingers posteriorly. The uterine incision was closed while the introducer is in situ , then the introducer will be removed vaginally at the end of CS. Six weeks postpartum; Patients will be followed as in the classic technique group.

Intervention Type: DEVICE

cesarian section

Under general or spinal anathesia , the abdomen is opened in layers , the bladder is dissected downwards . The uterus is incised at its lower segment \& the fetus is extracted , followed by the placenta \& membranes . The CU T 380 IUD is inserted either by the classic technique or the standard technique . The uterus is closed in 2 layers by continous non - locked sutures .Proper hemostasis \& closure of the abdomen in layers .

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• pregnant , full term patients , scheduled for elective CS.

Exclusion Criteria

• contraindications for IUD insertion ( chorioamnionitis , congenital uterine malformations ) - Patient refusing IUD contraception.
• Patients with intra-operative bleeding or vital instability.
• Active genital infection at time of insertion.
• Medical disorders e.g. : cardiac , bleeding disorders , T.B. .. etc.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Bassiony Dabian

lecturer of obstetrics and gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kasr Alainy outpatient infertility clinic

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

bassiony dabian, MD

Role: CONTACT

bassiony.dabian@gmail.com

1095195513

Facility Contacts

bassiony dabian, MD

Role: primary

bassiony.dabian@gmail.com

1095195513

References

Cleland J, Ali M, Benova L, Daniele M. The promotion of intrauterine contraception in low- and middle-income countries: a narrative review. Contraception. 2017 Jun;95(6):519-528. doi: 10.1016/j.contraception.2017.03.009. Epub 2017 Mar 30.

Reference Type: BACKGROUND

PMID: 28365165 (View on PubMed)

Goldstuck ND, Steyn PS. Insertion of intrauterine devices after cesarean section: a systematic review update. Int J Womens Health. 2017 Apr 18;9:205-212. doi: 10.2147/IJWH.S132391. eCollection 2017.

Reference Type: BACKGROUND

PMID: 28458581 (View on PubMed)

Sunder, G. and Snigdha, G. (2016) Displaced Intrauterine Device: A Retrospective Study. The Journal of Medical Research, 2, 41-43.

Reference Type: BACKGROUND

Other Identifiers

MS-673-2021

Identifier Type: -

Identifier Source: org_study_id