Safety and Efficacy of Immediate Post Placental IUD Insertion in Patients Undergoing Cesarean Delivery

IUD Clinical Trial

Official title:

The Safety and Efficacy of Immediate Post Placental IUD Insertion Versus the Post Puerperal IUD Insertion in Patients Undergoing Cesarean Delivery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04630548
• Other study ID #: 1401172
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: November 2020
• Source: Cairo University
• Contact: Moutaz M Elsherbini, MD
• Phone: 01001588300
• Email: Mizosherbini[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sixty six women who plan to deliver a live birth singleton via cesarean delivery who desire a Copper IUD for postpartum contraception will be approached for study participation thenvwill be randomized equally into two groups using computer generated numbers.

Group (A): (n=33) women IUD insertion post placental delivery (within 10mins) Group (B):

(n=33) women IUD insertion post puerperal ( 6 to 8 weeks postpartum). Primary outcome will include IUD expulsion rate in both groups. Secondary outcomes will include other complications rates: missed threads (not seen by speculum examination), displaced IUD (more than 2 cm from the fundus in ultrasound), heavy puerperal bleeding, abdominal discomfort), Pregnancy rate, Discontinuation of the IUD usage and Satisfaction rate.

Description:

Full history taking including a detailed history including medical and obstetric history, full obstetric examination and ultrasound evaluation to confirm gestational age and to exclude any of the exclusion criteria. Women who plan to deliver a live birth singleton via cesarean delivery at Kasr El-Ainy teaching will be considered for inclusion in the study. Women who desire a Copper IUD for postpartum contraception will be approached for study participation. The postpartum contraception plan will be documented during their prenatal course. It is also addressed by the obstetrical team upon admission to Labor & Delivery at El-Kasr El-Ainy teaching hospital. The obstetrical team will identify subjects who present in labor who meet the criteria and express interest in intrauterine contraception. Immediately after cesarean delivery, consented subjects will be randomized to immediate post placental IUD placement within 10 minutes or IUD placement at their routine standard postpartum visit (6 to 8 weeks postpartum).

For women randomized to the immediate post placental IUD insertion (n=33) the following will be done:

• after placental delivery, uterine cavity will be examined to exclude the presence of malformations or fibroids.

• Uterus will be stabilized by grasping it at fundus and the copper IUD (CuT 380 PREGNA IUD) will be placed (within 10 minutes following the placental delivery) through the uterine wall incision high up in the uterine fundus (either by hand or using its applicator).

• Before closing the uterine incision, the IUD strings will be guided to the lower uterine segment without trimming (If the cervix is closed, it should be dilated from above using a dilator).

• Enough care should be taken not to dislodge the IUD from its fundal position or to include the strings in uterine sutures.

• The IUD threads will protrude through the cervix in some cases its trimming will be done during follow-up if the patient is feeling any discomfort.

• Before discharge, the patient will be given a card including the intervention done (date & procedure), the follow-up schedule and investigator contacts. Also, they will be informed about normal postpartum symptoms, IUD side effects & possible complications (abdominal cramps, heavy puerperal bleeding, expulsion or protrusion of string) and instruct to seek medical help (to call the principle investigator) if any of the following warning signs have happened (severe lower abdominal pain, severe vaginal bleeding, infected discharge or lochia, fever, IUD expulsion & suspicion of pregnancy).

Subjects who are randomized for IUD insertion at their post puerperal visit will be assisted in scheduling a postpartum visit and IUD placement with their usual obstetrical care provider.

For women randomized for IUD insertion at their postpartum visit (n=33) the following will be done:(n=33):

• IUD will be inserted 6 - 8 weeks following caesarean delivery (during the post puerperal visit).

• Vaginal speculum will be inserted to expose the cervix & to exclude concomitant infection or bleeding.

• The anterior lip of the cervix will be grasped using ring forceps followed by uterine sounding to assess uterine cavity length.

• The IUD loaded sheath applicator (CuT 380 PREGNA IUD) will be introduced gently through the cervical canal and advanced slowly towards the uterine fundus.

• When fundal placement is confirmed, IUD will be released & the sheath will be withdrawn followed by trimming of the IUD string at 1 cm below the level of cervix.

• Following the insertion, transvaginal ultrasound (TVUS) will be done to assure fundal placement.

• Difficulties in insertion and patient discomfort will be recorded. Before leaving the clinic, the patient will be given a card including the intervention done (date & procedure), the follow-up schedule and investigator contacts. Also, they will be informed about potential IUD side effects & possible complications (abdominal cramps, vaginal bleeding, expulsion) and instruct to seek medical help (to call the principle investigator) if any of the following warning signs have happened (severe lower abdominal pain, severe vaginal bleeding, infected discharge, fever, IUD expulsion & suspicion of pregnancy).

All women who are going to have their IUD placement in post puerperal visits their contact numbers will be taken.

follow-up visits at 6 weeks ,3 & 6 months post-insertion will be scheduled. At 6 weeks post-insertion visit, participants (will be assessed via ultrasound and (to detect IUD expulsion or displacement) and speculum examination ( to detect presence of IUD threads).

At 3 months post-insertion visit, all subjects will be examined. Examination will include ultrasound (to detect IUD expulsion or displacement) and speculum examination ( to detect presence of IUD threads if not detected at 6 weeks post-insertion visit).

At 6 months post-insertion visit, all subjects will be examined & answering a simple questionnaire. Examination will include ultrasound (to detect IUD expulsion or displacement) and speculum examination ( to detect presence of IUD threads if not detected at 3 months post-insertion visit). The questionnaire will include questions regarding they have had a known expulsion, pregnancy event, or elective IUD removal and about the ease of placement and overall satisfaction with the timing of placement.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: April 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Singleton full term pregnancy at =37 weeks gestation confirmed by LMP and first trimesteric ultrasound.

• Desired copper IUD placement for postpartum contraception.

• Candidate for cesarean delivery.

• Regional anesthesia.

Exclusion Criteria:

• Anatomic uterine abnormalities distorting the uterine cavity (obstructive myomata, bicornuate, septate, etc)

• Chorioamnionitis (also consider other risk factors such as prolonged rupture of membranes >18 hours, prolonged labor >24 hours, fever >38C).

• Puerperal sepsis.

• Unresolved postpartum hemorrhage.

• Known or suspected untreated endocervical gonorrhea, chlamydia.

• Wilson's disease, copper allergy (Paragard only).

• Known or suspected cervical or endometrial cancer or pelvic tuberculosis.

• Prolonged procedure > 2 hours.

• Preoperative hemoglobin 9.5 gm/dl.

Related Conditions & MeSH terms

• IUD

Intervention

Device:
• Intrauterine copper device
The obstetrical team will identify subjects who present in labor who meet the criteria and express interest in intrauterine contraception. Immediately after cesarean delivery, consented subjects will be randomized to immediate post placental IUD placement within 10 minutes or IUD placement at their routine standard postpartum visit (6 to 8 weeks postpartum).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IUD expulsion rate	to measure the frequency of IUD expulsion (IUD not found in ultrasound) following insertion by ultrasound examination.	6 months (following the insertion)
Secondary	Missed threads rate (threads not seen by speculum examination)	to measure the frequency of absent threads (threads not seen by speculum examination) following insertion.	6 months (following the insertion)
Secondary	displaced IUD rate	to measure the frequency of displaced IUD (IUD more than 2 cm from the uterine fundus in ultrasound) following insertion.	6 months (following the insertion)
Secondary	pregnancy rate	occurrence of any pregnancy event	within the 1st 6 months after insertion
Secondary	satisfaction rate	by using questionnaire that include questions regarding they have had a known expulsion, pregnancy event, or elective IUD removal and about the ease of placement and overall satisfaction with the timing of placement.	6 months after insertion