New Method of IUD Insertion During Cesarian Section

NCT05756998 | Unknown

• 1 other identifier: MS-673-2021
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Contraception

Keywords

IUD; cesarian section; expulsion; postpartum

Outcome Measures

Primary Outcomes (2)

• accuracy of IUD position.

  using ultrasound the position of IUD by measuring the distance between the IUD \& the fundus of the uterus.

  3 months

• visibility of the threads of IUD.

  using a cusco speculum , the IUD threads are inspected.

  3 months

Secondary Outcomes (2)

• complications of IUD

  1 month

• patient overall satisfaction about the new technique

  3 months

Study Arms (2)

classic technique

ACTIVE COMPARATOR

Device: Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) (classic technique); Procedure: cesarian section

new technique

EXPERIMENTAL

Device: Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) ( New technique); Procedure: cesarian section

Interventions

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

classic technique

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

new technique

cesarian section 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 .

classic technique; new technique

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: pregnant patients attending to kasr Alainy Obstetrics and Gynecology Hospital for caesarian section .
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy outpatient infertility clinic

Cairo, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 28365165 BACKGROUND

• 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.

  PMID: 28458581 BACKGROUND

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

  BACKGROUND

MeSH Terms

Interventions

Cesarean Section

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

bassiony dabian, MD

CONTACT

1095195513; bassiony.dabian@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of obstetrics and gynecology

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: March 7, 2023
• Study Start: February 2, 2022
• Primary Completion: February 28, 2023
• Study Completion: March 15, 2023
• Last Updated: March 7, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)