Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06023849
Status:
RECRUITING
Last Update Posted:
2023-09-05
First Post:
2023-08-06
Brief Title:
Trans Caesarean Intra Uterine Contraceptive Device Insertion Versus Conventional Postpartum 6 Weeks Insertion
Sponsor:
Al-Azhar University
Organization:
Al-Azhar University
Study Overview
Official Title:
Trans Caesarean Intra Uterine Contraceptive Device Insertion Versus Conventional Postpartum 6 Weeks Insertion
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IUDinsertion
Brief Summary:
To compare immediate post-placental intrauterine contraceptive device insertion versus conventional placement at 6 weeks interval often referred to as delayed or interval insertion as regard to-
1 Patient satisfaction
2 Expulsion rate
3 Complications
1 Patient satisfaction
2 Expulsion rate
3 Complications
Detailed Description:
Until the 1960s Intrauterine devices IUCDs and condoms were the only artificial methods for the control of fertility Nowadays despite the presence of 12 contraceptive methods which include 9 modern methods pill IUD injectable implant vaginal methods diaphragm and contraceptive foam or jelly male condom female sterilization male sterilization and emergency contraception and 3 traditional methods periodic abstinence withdrawal and prolonged breastfeeding the insertion of an IUCD still the second most prevalent method of family planning used worldwide 136 after female sterilization 205 among women of reproductive age who are married or cohabiting
In Egypt Egypt Demographic and Health Survey 2014 findings revealed that 59 percent of currently married women in Egypt are currently using a contraceptive method The most widely used method is the IUD followed by the pill and injectables Thirty percent of currently married women are using the IUD 16 percent are relying on the pill and 9 percent are employing injectables Relatively small proportions of women are using other modern methods eg 1 percent reported currently using female sterilization Two percent of women report use of traditional methods
There are two ways used in IUD insertion in the postpartum period or immediate post-placental IUD insertion in which the insertion of IUD occurs within ten minutes after placenta delivery and after the puerperium after puerperal or interval period Intrauterine device insertion during cesarean section was first introduced in 1967 by Zerzavy by suturing the IUD to the posterior uterine fundus Research in China and Belgium introduced post-placental IUD insertion technique during cesarean delivery with placed an IUD as high as possible in the fundus without suturing the fundus wall
Intrauterine device insertion during early postpartum period is the most effective reversible contraceptive methods for many mothers because the contraception motivation is high and it doesnt interfere with breast feeding On the other hand without an effective contraception in the first six weeks woman may be accidentally pregnant Hence the mother prefers to insert IUD during cesarean delivery
As cesarean section CS rates are rising in all countries IUD insertion at the time of CS creates an opportunity to increase access to long-acting reversible contraception methods Conversely a previous CS scar may deter access to interval insertion of an IUD if a previous CS may result in difficulty with insertion andor future IUD problems
Inserting an IUD at the time of CS is a very attractive option It adds very little time and cost to the procedure The patient does not have to come back especially for follow-up and there is no risk of primary perforation secondary perforation is possible as it is performed under direct vision
In Egypt Egypt Demographic and Health Survey 2014 findings revealed that 59 percent of currently married women in Egypt are currently using a contraceptive method The most widely used method is the IUD followed by the pill and injectables Thirty percent of currently married women are using the IUD 16 percent are relying on the pill and 9 percent are employing injectables Relatively small proportions of women are using other modern methods eg 1 percent reported currently using female sterilization Two percent of women report use of traditional methods
There are two ways used in IUD insertion in the postpartum period or immediate post-placental IUD insertion in which the insertion of IUD occurs within ten minutes after placenta delivery and after the puerperium after puerperal or interval period Intrauterine device insertion during cesarean section was first introduced in 1967 by Zerzavy by suturing the IUD to the posterior uterine fundus Research in China and Belgium introduced post-placental IUD insertion technique during cesarean delivery with placed an IUD as high as possible in the fundus without suturing the fundus wall
Intrauterine device insertion during early postpartum period is the most effective reversible contraceptive methods for many mothers because the contraception motivation is high and it doesnt interfere with breast feeding On the other hand without an effective contraception in the first six weeks woman may be accidentally pregnant Hence the mother prefers to insert IUD during cesarean delivery
As cesarean section CS rates are rising in all countries IUD insertion at the time of CS creates an opportunity to increase access to long-acting reversible contraception methods Conversely a previous CS scar may deter access to interval insertion of an IUD if a previous CS may result in difficulty with insertion andor future IUD problems
Inserting an IUD at the time of CS is a very attractive option It adds very little time and cost to the procedure The patient does not have to come back especially for follow-up and there is no risk of primary perforation secondary perforation is possible as it is performed under direct vision
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None