Trial Outcomes & Findings for Histerectomy Vs Partial Myometrial Resection for Placenta Accreta Spectrum (NCT NCT05013749)

NCT ID: NCT05013749

Last Updated: 2024-11-25

Results Overview

Number of patients who agree to participate, out of the total number of eligible patients

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

6 weeks

Results posted on

2024-11-25

Participant Flow

Participant milestones

Participant milestones
Measure	Hysterectomy Hysterectomy: An incision will be made above the level of the placenta, delivering the newborn. Uterotonics will be administered, and spontaneous delivery of the placenta will be awaited using gentle traction. The absence of spontaneous separation of the placenta will confirm the diagnosis of PAS, the patient will undergo to hysterectomy. The complete removal of the uterus will be attempted, including the cervix, the duration of the intervention and intraoperative blood loss will be recorded, as well as the damage to organs neighboring the uterus. In this arm of the study, to hysterectomy will be performed in 100% of patients	Partial Myometrial Resection Partial myometrial resection: The technique described by Palacios-Jaraquemada et al5. will be followed. Briefly, the uterus will be dissected to free it from the posterior wall of the bladder to the cervix. The vesicouterine vessels will be ligated and the parametrial space will be visualized. The hysterotomy will be performed in the upper segment, immediately above the area of invasion of the myometrium. The entire invaded myometrium and the entire placenta will be removed. The uterus will repair itself in one or two layers. Intrauterine balloon tamponade will be used if indicated.
Overall Study STARTED	31	29
Overall Study Participants That Received a Different Intervention Than They Were Originally Randomized to	7	9
Overall Study COMPLETED	24	18
Overall Study NOT COMPLETED	7	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Hysterectomy Hysterectomy: An incision will be made above the level of the placenta, delivering the newborn. Uterotonics will be administered, and spontaneous delivery of the placenta will be awaited using gentle traction. The absence of spontaneous separation of the placenta will confirm the diagnosis of PAS, the patient will undergo to hysterectomy. The complete removal of the uterus will be attempted, including the cervix, the duration of the intervention and intraoperative blood loss will be recorded, as well as the damage to organs neighboring the uterus. In this arm of the study, to hysterectomy will be performed in 100% of patients	Partial Myometrial Resection Partial myometrial resection: The technique described by Palacios-Jaraquemada et al5. will be followed. Briefly, the uterus will be dissected to free it from the posterior wall of the bladder to the cervix. The vesicouterine vessels will be ligated and the parametrial space will be visualized. The hysterotomy will be performed in the upper segment, immediately above the area of invasion of the myometrium. The entire invaded myometrium and the entire placenta will be removed. The uterus will repair itself in one or two layers. Intrauterine balloon tamponade will be used if indicated.
Overall Study Patients without signs of PAS in the intraoperative staging. US false positive	7	2
Overall Study Did not meet the requirements for OSCS after intraoperative staging.	0	9

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hysterectomy n=31 Participants An incision will be made above the level of the placenta, delivering the newborn. Uterotonics will be administered, and spontaneous delivery of the placenta will be awaited using gentle traction. The absence of spontaneous separation of the placenta will confirm the diagnosis of PAS, the patient will undergo to hysterectomy. The complete removal of the uterus will be attempted, including the cervix, the duration of the intervention and intraoperative blood loss will be recorded, as well as the damage to organs neighboring the uterus. In this arm of the study, to hysterectomy will be performed in 100% of patients	Partial Myometrial Resection n=29 Participants The technique described by Palacios-Jaraquemada et al5. will be followed. Briefly, the uterus will be dissected to free it from the posterior wall of the bladder to the cervix. The vesicouterine vessels will be ligated and the parametrial space will be visualized. The hysterotomy will be performed in the upper segment, immediately above the area of invasion of the myometrium. The entire invaded myometrium and the entire placenta will be removed. The uterus will repair itself in one or two layers. Intrauterine balloon tamponade will be used if indicated.	Total n=60 Participants Total of all reporting groups
Age, Customized Maternal age (years)	33.13 years STANDARD_DEVIATION 4.26 • n=31 Participants	33.45 years STANDARD_DEVIATION 4.56 • n=29 Participants	33.28 years STANDARD_DEVIATION 4.38 • n=60 Participants
Sex/Gender, Customized Female	31 Participants n=31 Participants	29 Participants n=29 Participants	60 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Body mass index 18-24	10 kg/m^2 n=31 Participants	8 kg/m^2 n=29 Participants	18 kg/m^2 n=60 Participants
Body mass index 25-29	13 kg/m^2 n=31 Participants	12 kg/m^2 n=29 Participants	25 kg/m^2 n=60 Participants
Body mass index ≥30	8 kg/m^2 n=31 Participants	9 kg/m^2 n=29 Participants	17 kg/m^2 n=60 Participants
Number of previous pregnancies 1	9 number of previous pregnancies n=31 Participants	7 number of previous pregnancies n=29 Participants	16 number of previous pregnancies n=60 Participants
Number of previous pregnancies 2	16 number of previous pregnancies n=31 Participants	8 number of previous pregnancies n=29 Participants	24 number of previous pregnancies n=60 Participants
Number of previous pregnancies ≥3	6 number of previous pregnancies n=31 Participants	14 number of previous pregnancies n=29 Participants	20 number of previous pregnancies n=60 Participants
Number of previous cesarean sections 1	18 Participants n=31 Participants	14 Participants n=29 Participants	32 Participants n=60 Participants
Number of previous cesarean sections 2	13 Participants n=31 Participants	13 Participants n=29 Participants	26 Participants n=60 Participants
Number of previous cesarean sections ≥3	0 Participants n=31 Participants	2 Participants n=29 Participants	2 Participants n=60 Participants
Number of previous dilatation curettage 0	24 Participants n=31 Participants	21 Participants n=29 Participants	45 Participants n=60 Participants
Number of previous dilatation curettage 1	7 Participants n=31 Participants	5 Participants n=29 Participants	12 Participants n=60 Participants
Number of previous dilatation curettage ≥2	0 Participants n=31 Participants	3 Participants n=29 Participants	3 Participants n=60 Participants
Gestational age at the time of diagnosis of PAS	33.10 weeks n=31 Participants	31.00 weeks n=29 Participants	32.75 weeks n=60 Participants
Diagnostic method of PAS Ultrasound	25 Participants n=31 Participants	21 Participants n=29 Participants	46 Participants n=60 Participants
Diagnostic method of PAS Ultrasound and Magnetic Resonance	6 Participants n=31 Participants	8 Participants n=29 Participants	14 Participants n=60 Participants
Antepartum vaginal bleeding	1 Participants n=31 Participants	0 Participants n=29 Participants	1 Participants n=60 Participants
Comorbidity Hypertensive disorder	1 participants n=31 Participants	1 participants n=29 Participants	2 participants n=60 Participants
Comorbidity Gestational diabetes	0 participants n=31 Participants	1 participants n=29 Participants	1 participants n=60 Participants
Gestational age at birth	35.00 weeks n=31 Participants	35.00 weeks n=29 Participants	35.00 weeks n=60 Participants

PRIMARY outcome

Timeframe: 6 weeks

Number of patients who agree to participate, out of the total number of eligible patients

Outcome measures

Outcome measures
Measure	Partial Myometrial Resection Partial myometrial resection: The technique described by Palacios-Jaraquemada et al5. will be followed. Briefly, the uterus will be dissected to free it from the posterior wall of the bladder to the cervix. The vesicouterine vessels will be ligated and the parametrial space will be visualized. The hysterotomy will be performed in the upper segment, immediately above the area of invasion of the myometrium. The entire invaded myometrium and the entire placenta will be removed. The uterus will repair itself in one or two layers. Intrauterine balloon tamponade will be used if indicated.	Hysterectomy n=64 Participants Hysterectomy: An incision will be made above the level of the placenta, delivering the newborn. Uterotonics will be administered, and spontaneous delivery of the placenta will be awaited using gentle traction. The absence of spontaneous separation of the placenta will confirm the diagnosis of PAS, the patient will undergo to hysterectomy. The complete removal of the uterus will be attempted, including the cervix, the duration of the intervention and intraoperative blood loss will be recorded, as well as the damage to organs neighboring the uterus. In this arm of the study, to hysterectomy will be performed in 100% of patients
Feasibility: Proportion of Eligible Patients Who Agree to Participate in the Study.	—	60 Participants

PRIMARY outcome

Timeframe: During surgery

Percentage of patients who entered the study but did not present macroscopic findings of placenta accreta spectrum during laparotomy.

Outcome measures

Outcome measures
Measure	Partial Myometrial Resection n=29 Participants Partial myometrial resection: The technique described by Palacios-Jaraquemada et al5. will be followed. Briefly, the uterus will be dissected to free it from the posterior wall of the bladder to the cervix. The vesicouterine vessels will be ligated and the parametrial space will be visualized. The hysterotomy will be performed in the upper segment, immediately above the area of invasion of the myometrium. The entire invaded myometrium and the entire placenta will be removed. The uterus will repair itself in one or two layers. Intrauterine balloon tamponade will be used if indicated.	Hysterectomy n=31 Participants Hysterectomy: An incision will be made above the level of the placenta, delivering the newborn. Uterotonics will be administered, and spontaneous delivery of the placenta will be awaited using gentle traction. The absence of spontaneous separation of the placenta will confirm the diagnosis of PAS, the patient will undergo to hysterectomy. The complete removal of the uterus will be attempted, including the cervix, the duration of the intervention and intraoperative blood loss will be recorded, as well as the damage to organs neighboring the uterus. In this arm of the study, to hysterectomy will be performed in 100% of patients
Screening Failure Percentage	2 Participants	7 Participants

PRIMARY outcome

Timeframe: During surgery

All patients had been randomized before surgery to a certain procedure; however, after performing intraoperative staging, it was identified that some women did not have signs of PAS (7 patients with false positive prenatal diagnosis, randomized to hysterectomy), so they were managed with OSCS, and that some women did not meet the criteria to perform OSCS (9 patients randomized to OSCS), so they were managed with hysterectomy;

Outcome measures

Outcome measures
Measure	Partial Myometrial Resection n=29 Participants Partial myometrial resection: The technique described by Palacios-Jaraquemada et al5. will be followed. Briefly, the uterus will be dissected to free it from the posterior wall of the bladder to the cervix. The vesicouterine vessels will be ligated and the parametrial space will be visualized. The hysterotomy will be performed in the upper segment, immediately above the area of invasion of the myometrium. The entire invaded myometrium and the entire placenta will be removed. The uterus will repair itself in one or two layers. Intrauterine balloon tamponade will be used if indicated.	Hysterectomy n=31 Participants Hysterectomy: An incision will be made above the level of the placenta, delivering the newborn. Uterotonics will be administered, and spontaneous delivery of the placenta will be awaited using gentle traction. The absence of spontaneous separation of the placenta will confirm the diagnosis of PAS, the patient will undergo to hysterectomy. The complete removal of the uterus will be attempted, including the cervix, the duration of the intervention and intraoperative blood loss will be recorded, as well as the damage to organs neighboring the uterus. In this arm of the study, to hysterectomy will be performed in 100% of patients
Percentage of Patients With Crossover Between Assigned Study Arms.	9 Participants	7 Participants

PRIMARY outcome

Timeframe: 42 days postpartum

Number of participants who completed follow-up at 42 days postpartum

Outcome measures

Outcome measures
Measure	Partial Myometrial Resection n=29 Participants Partial myometrial resection: The technique described by Palacios-Jaraquemada et al5. will be followed. Briefly, the uterus will be dissected to free it from the posterior wall of the bladder to the cervix. The vesicouterine vessels will be ligated and the parametrial space will be visualized. The hysterotomy will be performed in the upper segment, immediately above the area of invasion of the myometrium. The entire invaded myometrium and the entire placenta will be removed. The uterus will repair itself in one or two layers. Intrauterine balloon tamponade will be used if indicated.	Hysterectomy n=31 Participants Hysterectomy: An incision will be made above the level of the placenta, delivering the newborn. Uterotonics will be administered, and spontaneous delivery of the placenta will be awaited using gentle traction. The absence of spontaneous separation of the placenta will confirm the diagnosis of PAS, the patient will undergo to hysterectomy. The complete removal of the uterus will be attempted, including the cervix, the duration of the intervention and intraoperative blood loss will be recorded, as well as the damage to organs neighboring the uterus. In this arm of the study, to hysterectomy will be performed in 100% of patients
Number of Participants Who Completed the Follow-up Evaluation.	29 Participants	31 Participants

SECONDARY outcome

Timeframe: 6 weeks

Number of maternal deaths during the study period

Outcome measures

Outcome measures
Measure	Partial Myometrial Resection n=29 Participants Partial myometrial resection: The technique described by Palacios-Jaraquemada et al5. will be followed. Briefly, the uterus will be dissected to free it from the posterior wall of the bladder to the cervix. The vesicouterine vessels will be ligated and the parametrial space will be visualized. The hysterotomy will be performed in the upper segment, immediately above the area of invasion of the myometrium. The entire invaded myometrium and the entire placenta will be removed. The uterus will repair itself in one or two layers. Intrauterine balloon tamponade will be used if indicated.	Hysterectomy n=31 Participants Hysterectomy: An incision will be made above the level of the placenta, delivering the newborn. Uterotonics will be administered, and spontaneous delivery of the placenta will be awaited using gentle traction. The absence of spontaneous separation of the placenta will confirm the diagnosis of PAS, the patient will undergo to hysterectomy. The complete removal of the uterus will be attempted, including the cervix, the duration of the intervention and intraoperative blood loss will be recorded, as well as the damage to organs neighboring the uterus. In this arm of the study, to hysterectomy will be performed in 100% of patients
Maternal Death	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During surgery

Surgical bleeding calculated in milliliters