الفهرس 
Introductionيوجد فقط 14 صفحة متاحة للعرض العام
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المستخلص
Summary
his study was conducted at the department of Obstetrics and Gynecolocy, Ain Shams University, Maternity Hospital, Cairo Egypt, from February 2018 to December 2018, to investigate the rates of expulsion and complications between GyneFix CS 300 and Copper T380 A insertion immediately after placental delivery during cs at 6 weeks and 3 months follow up visits.
This was in collaboration with Prof. Dr. Dirk Wildemeersch (Ghent University, Belgium) who invented this device (GyneFix CS 300).
Inclusion criteria:
Healthy sexually active parous and primipara women
Inclusion characteristics include:
A subject will be considered for inclusion in the study if she meets all of the following criteria:
1. Generally healthy, pregnant women, 20-35 years of age.
2. Intact and anatomically normal uterus
3. Be willing to stay in the study for 3 months
4. Be able to return for follow-up at the designated times
5. Written informed consent
T
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Exclusion criteria:
1. The presence of infection of the uterus, clinical cervicitis or vaginitis (infection should be ruled out).
2. Suspicion of endometrial or uterine pathology such as congenital malformation of the uterus.
3. Large uterine fibromata (> 3 cm in diameter).
4. History of irregular cycles.
5. Heavy menstrual loss.
6. Blood clotting disorders and undiagnosed genital tract bleeding.
7. Thrombophlebitis, thrombosis or thromboembolic disorders.
8. Cerebrovascular accident, stroke, or transient ischemic attack.
9. Significant medical disease that in the medical opinion of the investigator is likely to interfere with patient ability to complete the entire trial.
10. Any cardiac, renal or hepatic disease.
11. Subjects receiving corticosteroid therapy or immuno-suppressive drugs.
Insertion of the GyneFix® CS IUD(Wildemeersch et al., 2014):-
Immediately following cesarean delivery and manual removal of the placenta, while bleeding is controlled, the uterus was lifted out of the abdominal cavity. Prior to insertion, the cavity was manually inspected for abnormalities precluding
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proper placement of the intrauterine IUD. The applicator was then inserted through the surgical incision up to the fundus in the midline. The broad applicator tip was easily palpated through the exterior fundal wall to determine positioning, without any risk of penetration or perforation of the fundal wall. The stylet carrying the IUD was then pushed forward until it became visible on the exterior surface to the uterus. The applicator was then removed, and forceps placed on the tail of the IUD. The noose of the anchoring system was then threaded with a biodegradable suture material such as Vicryl® 3-0 suture (Ethicon, Somerville, NJ, USA) or a generic equivalent. The threaded anchor was then retracted one millimeter below the serosa by exerting traction on the tail of the IUD. The passage of the anchor through the denser serosa layers was clearly felt. One end of the Vicryl absorbable suture was then secured to the serosa and knotted with its other end. The purpose of the Vicryl suture was to ensure retention while involution of the uterus occurs. Once uterine tone is returned to normal after several weeks, the Vicryl suture dissolves and retention is identical to that seen with the conventional anchored device. Finally, the tail was passed through the cervical canal and trimmed. The entire procedure takes approximately 3 to 4 minutes to perform.
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Follow up:
At each study visit, vital signs were evaluated and gynecological examination, including vaginal ultrasound was performed. Ultrasound assessments include checking the position of GyneFix - CS in the uterine cavity and measuring the distance of the anchor from the serosal surface of the uterus to evaluate correct placement of GyneFix CS. Ultrasonographic follow was also be prepared for cases of copperT-380A Tto measure the distance from the top of the device to the uterine fundus which shouldn’t exceed 2cm. Ultrasonographic follow up was done at 6 weeks and 3 months visits. Also the tail of GyneFix CS device and threads of CopperT380A IUD were inspected by vaginal examination.
All GyneFix CS group 30 cases attended the first 6-week follow-up visit, and all devices were in place as confirmed by ultrasonographic examination and the tail was visible in the vagina.
Removal in this visit for the first group was done for only one case for pain.
However, number of 6-week follow-up visit in the second group (Copper T380A IUD GROUP) was 28 cases with dropout rate 6.6% (2 cases didn’t return for follow-up ), the IUDs were in place confirmed also by ultrasonographic
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examination and the threads were in the vagina by inspection, excluding 2 cases of expulsion.
Removal in this visit for the second group was done for 4 cases, 2 of them were for pain, and the other 2 were for bleeding.
So, in the first follow-up visit (6-week follow-up) visit, there was no case of expulsion. Only one device was removed for pain , while for CopperT380A IUD, there were 2 cases of expulsion and 4 cases of removal ( 2 for bleeding and 2 for pain) .
The number of 3-month follow-up visit in the first group (GyneFix CS 300 IUD GROUP) was 27 cases of the 30 insertions with dropout rate 10 %. Only 1 case of expulsion which occurred approximately after 6 weeks post insertion which was thought to be caused by improper placement of the anchor too far from the serosa, or due to inadvertent or accidental pulling at the tail during or after the intervention, causing early dislodgement following absorption of the degradable suture.
Removing of another only one device was done in this visit for PID.
However, the remaining devices were in place confirmed by ultrasonographic examination and the tail was in the vagina by inspection.
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While, the number of the 3-month follow-up visit in the second group (Copper T380A IUD GROUP), was 21 cases of the 30 insertions with total dropout rate 30%. In this visit there were 4 cases of expulsion which occurred approximately after 6 weeks post insertion.
Removing was also done for only one case for PID.
The remaining IUDS were in place as confirmed by ultrasonographic examination and the threads were in the vagina by inspection.
The net result of this study showed statistically significant difference between the two groups according to expulsion rate.
For the technique of insertion of GyneFix CS 300, the progress in the learning of the insertion was related to the time and the number of cases.
The time needed for fixation of GyneFix CS 300 decreased overtime.
The main duration of fixation of IUD was 14 minutes for the first 10 applications, 8 minutes for the second 10 applications, and only 4-3 minutes for the last 10 cases.
So, the method is suitable for general obstetrical use and that only limited training is required